Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018762668

FEI Number

3018762668

Entity Name

PLASTI-MED PLASTIK MEDIKAL URUNLER SAN. VE TIC. LTD. STI.

City/State/Country

Tuzla Istanbul, TR

Establishment Address

Deri Osb Mahallesi Yan Sanayi Cad. No:13, Tuzla Istanbul 34956, TR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Plasti-med Plastik Medikal Urunler San. ve Tic. Ltd. Sti. (Owner Number: 10080023)

Owner / Operator Contact Address

Deri Osb Mahallesi Yan Sanayi Cad. No:13, Tuzla, TR-34 34956, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPIROMETER MOUTHPIECE 28 MM - 141 228 SPIROMETER MOUTHPIECE 30 MM - STERILE - 141 238 SPIROMETER MOUTHPIECE 28 MM - STERILE - 141 236 SPIROMETER MOUTHPIECE 33 MM - STERILE - 141 240 SPIROMETER MOUTHPIECE 30 MM - 141 230 SPIROMETER MOUTHPIECE 33 MM - 141 233 URINE BAG HANGER - 100 105 PEDIATRIC URINE BAG MALE - 100 201 PEDIATRIC URINE BAG FEMALE - 100 202 SUCTION CANISTER 1500ML - 160 211 SUCTION COLLECTION BAG 2000ML WITH ANTIFOAM (INCLUDING TUBE) - 160 203 9 1 SUCTION CANISTER 3000ML - 160 213 SUCTION COLLECTION BAG 3000ML WITHOUT TUBE AND WITH GEL - 160 201 3 4 SUCTION COLLECTION BAG 3000ML WITHOUT TUBE AND WITH ANTIFOAM, GEL - 160 201 1 3 4 SUCTION BAG FOUR CANISTER WITH TROLLEY 2LT'' - 160 236 SUCTION COLLECTION BAG 1200ML WITHOUT TUBE AND WITH GEL - 160 207 3 4 SUCTION COLLECTION BAG 3000ML WITHOUT TUBE AND WITH ANTIFOAM - 160 201 1 4 SUCTION BAG FOUR CANISTER WITH TROLLEY 3LT'' - 160 232 SUCTION COLLECTION BAG 1200ML (INCLUDING TUBE) - 160 207 9 SUCTION BAG TWO CANISTER WITH TROLLEY 1,5 LT'' - 160 233 SUCTION BAG TUBE 3,7M WITH KAPKON CONNECTOR - 160 332 SUCTION COLLECTION BAG 3000ML WITH ANTIFOAM, GEL - 160 201 1 3 SUCTION COLLECTION BAG 2000ML WITHOUT TUBE AND WITH ANTIFOAM, GEL - 160 203 1 3 4 SUCTION COLLECTION BAG 1200ML WITHOUT TUBE WITH DISINFECTANT AND GEL - 160 207 2 3 4 SUCTION COLLECTION BAG 1200ML WITHOUT TUBE WITH ANTIFOAM AND DISINFECTANT - 160 207 1 2 4 SUCTION COLLECTION BAG 1200ML - 160 207 SUCTION BAG TUBE 1,8M WITH KAPKON CONNECTOR - 160 322 SUCTION COLLECTION BAG 1000ML WITH GEL - 160 208 3 SUCTION COLLECTION BAG 1000ML WITH ANTIFOAM, GEL - 160 208 1 3 SUCTION COLLECTION BAG 2000ML WITHOUT TUBE AND WITH ANTIFOAM, DISINFECTANT - 160 203 1 2 4 SUCTION COLLECTION BAG 1200ML WITHOUT TUBE AND WITH ANTIFOAM - 160 207 1 4 SUCTION COLLECTION BAG 1500ML WITH ANTIFOAM, DISINFECTANT - 160 202 1 2 SUCTION COLLECTION BAG 1500ML - 160 202 SUCTION COLLECTION BAG 1200ML WITH ANTIFOAM AND GEL - 160 207 1 3 SUCTION BAG TWO CANISTER WITH TROLLEY 3LT'' - 160 231 SUCTION COLLECTION BAG 1500ML WITH DISINFECTANT, GEL - 160 202 2 3 SUCTION COLLECTION BAG 1500ML WITH DISINFECTANT, GEL, ANTIFOAM - 160 202 1 2 3 "I" CONNECTOR 8/8MM - 160 413 SUCTION COLLECTION BAG 1500ML WITHOUT TUBE AND WITH DISINFECTANT, GEL - 160 202 2 3 4 SUCTION COLLECTION BAG 1500ML WITH ANTIFOAM (INCLUDING TUBE) - 160 202 9 1 SUCTION BAG TUBE 3,7M - 160 331 SUCTION COLLECTION BAG 1500ML (INCLUDING TUBE) - 160 202 9 SUCTION COLLECTION BAG 3000ML - 160 201 SUCTION COLLECTION BAG 1000ML WITH DISINFECTANT - 160 208 2 SUCTION COLLECTION BAG 1500ML WITH GEL - 160 202 3 SUCTION COLLECTION BAG 2000ML- STERILE - 160 206 "I" CONNECTOR 6/6MM - 160 412 SUCTION COLLECTION BAG 3000ML WITH GEL - 160 201 3 SUCTION COLLECTION BAG 2000ML (INCLUDING TUBE) - 160 203 9 SUCTION BAG TUBE 100M - 160 325 SUCTION COLLECTION BAG 1500ML WITHOUT TUBE AND WITH GEL - 160 202 3 4 SUCTION COLLECTION BAG 2000ML - 160 203 SUCTION COLLECTION BAG 3000ML WITHOUT TUBE AND WITH ANTIFOAM, DISINFECTANT - 160 201 1 2 4 SUCTION COLLECTION BAG 2000ML WITHOUT TUBE AND WITH DISINFECTANT, GEL - 160 203 2 3 4 SUCTION COLLECTION BAG 2000ML WITH GEL - 160 203 3 SUCTION COLLECTION BAG 2000ML WITH DISINFECTANT, GEL, ANTIFOAM - 160 203 1 2 3 SUCTION COLLECTION BAG 2000ML WITH ANTIFOAM, GEL - 160 203 1 3 SUCTION BAG FOUR CANISTER WITH TROLLEY 1,5 LT'' - 160 234 SUCTION COLLECTION BAG 1500ML WITHOUT TUBE AND WITH DISINFECTANT - 160 202 2 4 SUCTION COLLECTION BAG 1200ML WITH ANTIFOAM AND DISINFECTANT - 160 207 1 2 SUCTION COLLECTION BAG 1200ML WITH DISINFECTANT AND GEL AND ANTIFOAM - 160 207 1 2 3 SUCTION COLLECTION BAG 1200ML WITHOUT TUBE WITH ANTIFOAM AND DISINFECTANT AND GEL - 160 207 1 2 3 4 SUCTION COLLECTION BAG 3000ML WITH GEL (INCLUDING TUBE) - 160 201 9 2 SUCTION COLLECTION BAG 2000ML WITH GEL (INCLUDING TUBE) - 160 203 9 2 SUCTION COLLECTION BAG 1000ML WITH ANTIFOAM, DISINFECTANT - 160 208 1 2 "I" CONNECTOR 5/11MM - 160 416 SUCTION COLLECTION BAG 1200ML WITH GEL - 160 207 1 SUCTION COLLECTION BAG 1500ML WITH DISINFECTANT - 160 202 2 SUCTION COLLECTION BAG 1500ML- STERILE - 160 205 SUCTION COLLECTION BAG 3000ML- STERILE - 160 204 SUCTION COLLECTION BAG 3000ML WITH DISINFECTANT - 160 201 2 SUCTION COLLECTION BAG 1200ML WITH DISINFECTANT - 160 207 2 SUCTION COLLECTION BAG 1000ML - 160 208 SUCTION COLLECTION BAG 1200ML WITHOUT TUBE AND WITH DISINFECTANT - 160 207 2 4 SUCTION COLLECTION BAG 1500ML WITHOUT TUBE AND WITH ANTIFOAM - 160 202 1 4 SUCTION SYSTEM FILTER - 160 221 SUCTION COLLECTION BAG 2000ML WITH ANTIFOAM, DISINFECTANT - 160 203 1 2 SUCTION BAG TUBE 1,8M - 160 321 SUCTION COLLECTION BAG 1500ML WITHOUT TUBE AND WITH ANTIFOAM, DISINFECTANT, GEL - 160 202 1 2 3 4 SUCTION COLLECTION BAG 3000ML (INCLUDING TUBE) - 160 201 9 SUCTION COLLECTION BAG 1500ML WITH GEL (INCLUDING TUBE) - 160 202 9 2 SUCTION BAG TUBE 1,8M -STERILE - 160 323 "I" CONNECTOR 5/8MM - 160 415 SUCTION COLLECTION BAG 2000ML WITH DISINFECTANT, GEL - 160 203 2 3 SUCTION COLLECTION BAG 1500ML WITHOUT TUBE AND WITH ANTIFOAM, GEL - 160 202 1 3 4 SUCTION COLLECTION BAG 1000ML WITH DISINFECTANT, GEL - 160 208 2 3 SUCTION CANISTER 2000ML - 160 212 SUCTION COLLECTION BAG 3000ML WITHOUT TUBE - 160 201 4 SUCTION COLLECTION BAG 2000ML WITHOUT TUBE AND WITH ANTIFOAM - 160 203 1 4 SUCTION COLLECTION BAG 1000ML WITH ANTIFOAM -160 208 1 SUCTION COLLECTION BAG 1500ML WITHOUT TUBE AND WITH ANTIFOAM, DISINFECTANT - 160 202 1 2 4 SUCTION COLLECTION BAG 2000ML WITHOUT TUBE AND WITH ANTIFOAM, DISINFECTANT, GEL - 160 203 1 2 3 4 "I" CONNECTOR 5/5MM - 160 411 SUCTION COLLECTION BAG 3000ML WITH ANTIFOAM (INCLUDING TUBE) - 160 201 9 1 SUCTION COLLECTION BAG 1000ML WITH ANTIFOAM, DISINFECTANT, GEL - 160 208 1 2 3 SUCTION COLLECTION BAG 3000ML WITHOUT TUBE AND WITH DISINFECTANT - 160 201 2 4 SUCTION COLLECTION BAG 1200ML WITH ANTIFOAM - 160 207 3 SUCTION COLLECTION BAG 1500ML WITH ANTIFOAM - 160 202 1 SUCTION COLLECTION BAG 2000ML WITH ANTIFOAM - 160 203 1 KAPKON CONNECTOR- STERILE - 160 404 SUCTION COLLECTION BAG 3000ML WITH DISINFECTANT (INCLUDING TUBE) - 160 201 9 3 KAPKON CONNECTOR - 160 403 SUCTION COLLECTION BAG 3000ML WITH DISINFECTANT, GEL, ANTIFOAM - 160 201 1 2 3 SUCTION COLLECTION BAG 3000ML WITHOUT TUBE AND WITH ANTIFOAM, DISINFECTANT, GEL - 160 201 1 2 3 4 SUCTION COLLECTION BAG 2000ML WITHOUT TUBE AND WITH DISINFECTANT - 160 203 2 4 SUCTION BAG TUBE 3,7M STERILE - 160 333 SUCTION COLLECTION BAG 3000ML WITH ANTIFOAM - 160 201 1 SUCTION COLLECTION BAG 3000ML WITH DISINFECTANT, GEL - 160 201 2 3 SUCTION COLLECTION BAG 2000ML WITHOUT TUBE AND WITH GEL - 160 203 3 4 SUCTION COLLECTION BAG 1500ML WITHOUT TUBE - 160 202 4 SUCTION COLLECTION BAG 2000ML WITH DISINFECTANT - 160 203 2 SUCTION COLLECTION BAG 1500ML WITH ANTIFOAM, GEL - 160 202 1 3 SUCTION COLLECTION BAG 1500ML WITH DISINFECTANT (INCLUDING TUBE) - 160 202 9 3 SUCTION COLLECTION BAG 3000ML WITH ANTIFOAM, DISINFECTANT - 160 201 1 2 SUCTION COLLECTION BAG 1200ML WITH DISINFECTANT AND GEL - 160 207 2 3 SUCTION COLLECTION BAG 1200ML WITHOUT TUBE - 160 207 4 SUCTION BAG TUBE 3,7M WITH KAPKON CONNECTOR STERILE - 160 334 "I" CONNECTOR 10/10MM - 160 414 SUCTION COLLECTION BAG 2000ML WITHOUT TUBE - 160 203 4 "I" CONNECTOR 7/11MM - 160 417 SUCTION COLLECTION BAG 2000ML WITH DISINFECTANT (INCLUDING TUBE) - 160 203 9 3 SUCTION COLLECTION BAG 3000ML WITHOUT TUBE AND WITH DISINFECTANT, GEL - 160 201 2 3 4 SUCTION COLLECTION BAG 1200ML WITHOUT TUBE WITH ANTIFOAM AND GEL - 160 207 1 3 4 SUCTION BAG TWO CANISTER WITH TROLLEY 2 LT'' - 160 235 SUCTION BAG TUBE 1,8M WITH KAPKON CONNECTOR-STERILE - 160 324 SUCTION BAG TUBE 6.1 M STERILE - 160 337 SUCTION BAG TUBE 3.1 M WITH KAPKON CONNECTOR-STERILE - 160 327 1 SUCTION BAG TUBE 6.1 M -STERILE - 160 337 2 SUCTION BAG TUBE 6.1 M WITH KAPKON CONNECTOR STERILE - 160 338 I CONNECTOR 5/11MM - STERILE - 160 426 SUCTION BAG TUBE 3.7 M WITH KAPKON CONNECTOR-STERILE -160 334 2 SUCTION BAG TUBE 1,8M -STERILE - 160 323 2 SUCTION BAG TUBE 1,8M WITH KAPKON CONNECTOR STERILE - 160 324 1 SUCTION BAG TUBE 3.1 M -STERILE - 160 326 1 DISPOSABLE SUCTION CANISTER SEMI RIGID LINER 3000ML - 160 1921 4 SUCTION BAG TUBE 3.1 M STERILE - 160 326 SUCTION BAG TUBE 1,8M STERILE - 160 323 1 DISPOSABLE SUCTION CANISTER SEMI RIGID LINER 1500ML - 160 1922 4 SUCTION BAG TUBE 3.7 M -STERILE - 160 333 1 SUCTION BAG TUBE 6.1 M WITH KAPKON CONNECTOR-STERILE - 160 338 2 SUCTION BAG TUBE 3.7 M WITH KAPKON CONNECTOR-STERILE -160 334 1 SUCTION BAG TUBE 3.1 M -STERILE - 160 326 2 DISPOSABLE SUCTION CANISTER SOFT LINER 3000ML - 160 1901 4 SUCTION BAG TUBE 6.1 M WITH KAPKON CONNECTOR-STERILE - 160 338 1 DISPOSABLE SUCTION CANISTER SEMI RIGID LINER 1000ML - 160 1924 4 DISPOSABLE SUCTION CANISTER SOFT LINER 1500ML - 160 1902 4 SUCTION BAG TUBE 3.1 M WITH KAPKON CONNECTOR-STERILE - 160 327 2 SUCTION BAG TUBE 3.7 M -STERILE - 160 333 2 SUCTION BAG TUBE 1,8M WITH KAPKON CONNECTOR-STERILE - 160 324 2 DISPOSABLE SUCTION CANISTER SOFT LINER 1000ML - 160 1904 4 SUCTION BAG TUBE 6.1 M -STERILE - 160 337 1 SUCTION BAG TUBE 3.1 M WITH KAPKON CONNECTOR-STERILE - 160 327 Poche Perforator - 150 201 ENDOSCOPIC ADAPTER - TUOHY BORST 9 FR ADAPTER HOOD LARGE - 470 101 HOOD SMALL - 470 111 HIGH CONCENTRATION OXYGEN MASK (ADULT) - 130 110 SILICON MASK NO:3 CHILD - 130 223 OXYGEN MASK ADULT - 130 103 SILICON MASK NO:1 INFANT - 130 221 DISPOSABLE AIR CUSHION MASK NO:2 PEDIATRIC - 130 212 SILICON MASK NO:4 SMALL ADULT - 130 224 DISPOSABLE AIR CUSHION MASK NO:5 ADULT - 130 215 DISPOSABLE AIR CUSHION MASK NO:3 CHILD - 130 213 DISPOSABLE AIR CUSHION MASK NO:4 SMALL ADULT - 130 214 DISPOSABLE AIR CUSHION MASK NO:1 INFANT - 130 211 SILICON MASK NO:5 ADULT - 130 225 SILICON MASK NO:0 NEONATAL - 130 220 HIGH CONCENTRATION OXYGEN MASK -ADULT (NEW TYPE) - 130 060 HIGH CONCENTRATION OXYGEN MASK (PEDIATRIC) - 130 111 DISPOSABLE AIR CUSHION MASK NO:0 NEONATAL - 130 210 OXYGEN MASK PEDIATRIC - 130 104 OXYGEN MASK/ADULT (NEW TYPE) - 130 053 OXYGEN MASK INFANT - 130 059 SILICON MASK NO:2 PEDIATRIC - 130 222 GUIDE WIRE 038" x 150 CM ZEBRA - 536018 GUIDEWIRE J TYPE 0,035'' 80 cm - 536037J OCEAN TOUCH 0,035*150 cm HYROPHILIC TIP ZEBRA GUIDEWIRE - 536045 ANGEL PTFE - NITINOL GUIDEWIRE WITH HYDROPHILIC TIP 038" X 150cm - 536024 HYDROPHILIC SLIPPY GUIDE WIRE 0,038"x150 CM - 536043 GUIDE WIRE 032" x 150 CM ZEBRA - 536016 AMPLATZ SUPER STIFF GUIDE WIRE 80 CM - 536037JR GUIDE WIRE 035" x 150 CM (STRAIGHT TIP) - 536029 GUIDE WIRE 035" x 150 CM (ANGLED) HYDROPHILIC - 536011 GUIDE WIRE 018" x 150 CM (STRAIGHT TIP) - 536025 GUIDEWIRE HYDROPHILIC 035"X150cm - both sides flexible DISTAL END STRAIGHT, DISTAL END J - NITINOL - 536040 GUIDE WIRE 038" x 150 CM (STRAIGHT TIP) - 536030 OCEAN TOUCH 0,038*150 cm HYROPHILIC TIP ZEBRA GUIDEWIRE - 536046 OCEAN TOUCH 0,032*150 cm HYROPHILIC TIP ZEBRA GUIDEWIRE - 536044 GUIDE WIRE 028" x 150 CM (STRAIGHT TIP) HYDROPHILIC - 536003 GUIDE WIRE 038" x 150 CM (STRAIGHT TIP) HYDROPHILIC - 536006 GUIDE WIRE 032" x 150 CM (J TYPE) - 536034 HYDROPHILIC SLIPPY GUIDE WIRE 0,035"x150 CM - 536042 GUIDE WIRE SUPER STIFF 0,035'' 150 cm - 536037 ANGEL- II TWO EDGE FLEXIBLE NITINOL GUIDE WIRE 035" X 150cm - 536038 GUIDE WIRE 035" x 150 CM ZEBRA - 536017 GUIDE WIRE 025" x 150 CM (STRAIGHT TIP) - 536026 GUIDE WIRE 032" x 150 CM (STRAIGHT TIP) HYDROPHILIC - 536004 GUIDE WIRE 025" x 150 CM (STRAIGHT TIP) HYDROPHILIC - 536002 GUIDE WIRE 035" x 150 CM (STRAIGHT TIP) HYDROPHILIC - 536005 ANGEL PTFE - NITINOL GUIDEWIRE WITH HYDROPHILIC TIP 035" X 150cm - 536023 GUIDE WIRE 032" x 150 CM (ANGLED) HYDROPHILIC - 536010 GUIDE WIRE 035" x 150 CM (J TYPE) - 536035 GUIDE WIRE 038" x 150 CM (ANGLED) HYDROPHILIC - 536012 GUIDE WIRE 028" x 150 CM (STRAIGHT TIP) - 536027 GUIDE WIRE 032" x 150 CM (STRAIGHT TIP) - 536028 GUIDE WIRE 038" x 150 CM (J TYPE) - 536036 KIDNEY BOWL - 950 012 VOMIT BAG - 950 021 NASAL OXYGEN CANNULA/INFANT - 130 113 NASAL OXYGEN CANNULA ADULT - 130 101 NASAL OXYGEN CANNULA ADULT-7 Meter - 130 105 NASAL OXYGEN CANNULA PEDIATRIC - 130 102 VAGINAL SPECULUM- LARGE - 190 101 SCREWED VAGINAL SPECULUM-MEDIUM - 190 202 VAGINAL SPECULUM- MEDIUM - 190 102 CAMERA COVER (CIRCLED RING) - 170 201 CAMERA COVER - 170 101 SILICON MASK NO:2 PEDIATRIC - 130 222 SILICON MASK NO:5 ADULT - 130 225 SILICON MASK NO:1 INFANT - 130 221 SILICON MASK NO:3 CHILD - 130 223 DISPOSABLE AIR CUSHION MASK NO:0 NEONATAL-130 210 DISPOSABLE AIR CUSHION MASK NO:2 PEDIATRIC-130 212 DISPOSABLE AIR CUSHION MASK NO:4 SMALL ADULT-130 214 DISPOSABLE AIR CUSHION MASK NO:3 CHILD-130 213 SILICON MASK NO:4 SMALL ADULT - 130 224 DISPOSABLE AIR CUSHION MASK NO:1 INFANT-130 211 DISPOSABLE AIR CUSHION MASK NO:5 ADULT-130 215 SILICON MASK NO:0 NEONATAL - 130 220 DISPOSABLE AIR CUSHION MASK NO:6 ADULT-130 216 STONE BASKET 4 FR 4 WIRE 90 CM TIPLESS NITINOL - 532017 STONE BASKET 1.9 FR 4 WIRE 120 CM TIPLESS NITINOL - 532042 STONE BASKET 4 FR 5 WIRE 90 CM HELICAL - 532006 STONE BASKET 2,2 FR 3 WIRES 115 cm - 532046 STONE BASKET 5 FR 4 WIRE 90 CM FLAT WIRE - 532011 PERKUTAN BASKET (PERK) 12 FR 38 CM NITINOL - 532038 STONE BASKET 5 FR 5 WIRE 90 CM HELICAL - 532007 STONE BASKET 2.4 FR 4 WIRE 90 CM TIPLESS NITINOL - 532015 STONE BASKET 4 FR 4 WIRE 90 CM HELICAL - 532002 STONE BASKET 2.2 FR 4 WIRE 120 CM TIPLESS NITINOL - 532041 STONE BASKET 3 FR 4 WIRE 90 CM FLAT WIRE - 532009 STONE BASKET 3 FR 5 WIRE 90 CM HELICAL - 532005 PERKUTAN BASKET (PERK) 10 FR 38 CM NITINOL - 532039 STONE BASKET 3 FR 4 WIRE 90 CM HELICAL - 532001 STONE GRASPER 3 FR 90 CM (TRIPRONG) - 532035 SPIRAL STONE HOLDER 3 FR 120 cm - 532047 STONE BASKET 3 FR 4 WIRE 120 CM TIPLESS NITINOL - 532024 STONE BASKET 1,7 FR 3 WIRES 115 cm - 532045 STONE BASKET 4 FR 4 WIRE 120 CM TIPLESS NITINOL - 532025 STONE BASKET 1.5 FR 4 WIRE 120 CM TIPLESS NITINOL - 532040 STONE BASKET 2.4 FR 4 WIRE 120 CM TIPLESS NITINOL - 532023 STONE BASKET 3 FR 4 WIRE 90 CM TIPLESS NITINOL - 532016 STONE BASKET 3 FR 6 WIRE 120 CM TIPLESS NITINOL - 532044 STONE BASKET 4 FR 4 WIRE 90 CM FLAT WIRE - 532010 STONE BASKET 5 FR 4 WIRE 90 CM HELICAL - 532003 STONE GRASPER 4 FR 90 CM (TRIPRONG) - 532036 STONE BASKET 2.2 FR 6 WIRE 120 CM TIPLESS NITINOL - 532043 AIRWAY NO:6/110 - 200 109 AIRWAY NO:000/30 - 200 101 AIRWAY NO:2/70 - 200 105 AIRWAY NO:4/90 - 200 107 AIRWAY NO:5/100 - 200 108 AIRWAY NO:00/40 - 200 102 AIRWAY NO:0/50 - 200 103 AIRWAY NO:1/60 - 200 104 AIRWAY NO:3/80 - 200 106 NOSE CLIP for SFT - 141 110 ENDOTRACHEAL STYLET 04 CH - 220 104 ENDOTRACHEAL STYLET 12 CH - 220 112 ENDOTRACHEAL STYLET 08 CH - 220 108 ENDOTRACHEAL STYLET 06 CH - 220 106 ENDOTRACHEAL STYLET 10 CH - 220 110 ENDOTRACHEAL STYLET 16 CH - 220 116 BREATHING CIRCUIT- CORRUGATED HEATED WIRE INFANT - 489 061 BREATHING CIRCUIT-CORRUGATED IPPB PEDIATRIC CLOSED SYSTEM - 489 235 S BREATHING CIRCUIT-SMOOTHBORE DOUBLE WATER TRAP INFANT - 486 511 S ANESTHESIA CIRCUIT - EXTENDABLE PEDIATRIC + 1 M LIMB + BREATHING BAG - 482 501 ANESTHESIA CIRCUIT -SMOOTHBORE ADULT - 481 001 BREATHING CIRCUIT - EXTENDABLE SINGLE WATER TRAP PEDIATRIC + 1 M LIMB + BREATHING BAG - 488 201 S BREATHING CIRCUIT-EXTENDED IPPB PEDIATRIC - 489 285 BREATHING CIRCUIT - CORRUGATED SINGLE WATER TRAP ADULT + 0,8 M LIMB + BREATHING BAG - 483 201 S BREATHING CIRCUIT-EXTENDED IPPB PEDIATRIC CLOSED SYSTEM - 489 275 S BREATHING CIRCUIT- CORRUGATED WATER TRAP HEATED WIRE INFANT - 489 071 BREATHING CIRCUIT-EXTENDED IPPB ADULT - 489 281 S BREATHING CIRCUIT - CORRUGATED DOUBLE WATER TRAP PEDIATRIC + 0,8 M LIMB - 484 401 S BREATHING CIRCUIT - SMOOTHBORE SINGLE WATER TRAP PEDIATRIC + 0,8 M LIMB + BREATHING BAG - 486 201 S BREATHING CIRCUIT - CORRUGATED NEONATAL - 484 601 BREATHING CIRCUIT - CORRUGATED DOUBLE WATER TRAP PEDIATRIC + 0,8 M LIMB + BREATHING BAG - 484 501 S BREATHING CIRCUIT - CORRUGATED DOUBLE WATER TRAP ADULT - 483 301 S ANESTHESIA CIRCUIT -SMOOTHBORE PEDIATRIC - 481 301 S ANESTHESIA CIRCUIT -SMOOTHBORE PEDIATRIC + 0,8 M LIMB + BREATHING BAG - 481 501 S BREATHING CIRCUIT - SMOOTHBORE SINGLE WATER TRAP PEDIATRIC + 0,8 M LIMB + BREATHING BAG - 486 201 BREATHING CIRCUIT T CONNECTOR - 489 601 01 BREATHING CIRCUIT-CORRUGATED HEATED WIRE ADULT - 489 001 S BREATHING CIRCUIT- DOUBLE LINE TRANSPORT VENTILATOR CIRCUIT EXTENDED PEDIATRIC - 489 291 S BREATHING CIRCUIT-SMOOTHBORE IPPB ADULT CLOSED SYSTEM - 489 251 S BREATHING CIRCUIT-SMOOTHBORE DOUBLE WATER TRAP INFANT - 486 511 BREATHING CIRCUIT-SMOOTHBORE SINGLE WATER TRAP INFANT - 485 211 BREATHING CIRCUIT-EXTENDED IPPB ADULT CLOSED SYSTEM - 489 271 S BREATHING CIRCUIT - SMOOTHBORE DOUBLE WATER TRAP ADULT + 0,8 M LIMB - 485 401 S BREATHING CIRCUIT-EXTENDED IPPB ADULT - 489 281 BREATHING CIRCUIT - CORRUGATED DOUBLE WATER TRAP ADULT - 483 301 BREATHING CIRCUIT- (COAXIAL) CIRCUIT BASIC/ ADULT+1M LIMB - 489 302 S BREATHING CIRCUIT - CORRUGATED DOUBLE WATER TRAP PEDIATRIC + 0,8 M LIMB + BREATHING BAG - 484 501 BREATHING CIRCUIT - SMOOTHBORE SINGLE WATER TRAP PEDIATRIC - 486 001 BREATHING CIRCUIT - CORRUGATED SINGLE WATER TRAP ADULT + 0,8 M LIMB - 483 101 S ANESTHESIA CIRCUIT -SMOOTHBORE PEDIATRIC + 0,8 M LIMB - 481 401 S BREATHING CIRCUIT- (COAXIAL) CIRCUIT BASIC/ PEDIATRIC - 489 311 BREATHING CIRCUIT - SMOOTHBORE DOUBLE WATER TRAP PEDIATRIC + 0,8 M LIMB - 486 401 BREATHING CIRCUIT-CORRUGATED WATER TRAP HEATED WIRE PEDIATRIC - 489 021 S ANESTHESIA CIRCUIT -CORRUGATED PEDIATRIC + 0,8 M LIMB - 480 401 S BREATHING CIRCUIT- CORRUGATED IPPB WITH NEBULISER ADULT - 489 201 S BREATHING CIRCUIT- CORRUGATED WATER TRAP HEATED WIRE INFANT - 489 071 S BREATHING CIRCUIT - SMOOTHBORE DOUBLE WATER TRAP PEDIATRIC + 0,8 M LIMB - 486 401 S BREATHING CIRCUIT - EXTENDABLE SINGLE WATER TRAP PEDIATRIC - 488 001 BREATHING CIRCUIT-SMOOTHBORE IPPB WITH NEBULISER ADULT - 489 221 S BREATHING CIRCUIT - CORRUGATED SINGLE WATER TRAP PEDIATRIC + 0,8 M LIMB - 484 101 S BREATHING CIRCUIT - CORRUGATED DOUBLE WATER TRAP ADULT + 0,8 M LIMB - 483 401 ANESTHESIA CIRCUIT -SMOOTHBORE PEDIATRIC - 481 301 BREATHING CIRCUIT - SMOOTHBORE DOUBLE WATER TRAP PEDIATRIC - 486 301 S BREATHING CIRCUIT - SMOOTHBORE SINGLE WATER TRAP ADULT + 0,8 M LIMB - 485 101 S BREATHING CIRCUIT- (COAXIAL) CIRCUIT BASIC/ ADULT+1M LIMB+2L BREATHING BAG - 489 303 BREATHING CIRCUIT - CORRUGATED DOUBLE WATER TRAP ADULT + 0,8 M LIMB - 483 401 S BREATHING CIRCUIT- (COAXIAL) CIRCUIT BASIC/ ADULT - 489 301 BREATHING CIRCUIT T CONNECTOR - 489 601 01 S BREATHING CIRCUIT - SMOOTHBORE SINGLE WATER TRAP ADULT - 485 001 S BREATHING CIRCUIT-CORRUGATED IPPB PEDIATRIC CLOSED SYSTEM - 489 235 BREATHING CIRCUIT- DOUBLE LINE TRANSPORT VENTILATOR CIRCUIT SMOOTHBORE ADULT - 489 287 ANESTHESIA CIRCUIT - CORRUGATED ADULT + 0,8 M LIMB - 480 101 BREATHING CIRCUIT- CORRUGATED IPPB ADULT - 489 241 S ANESTHESIA CIRCUIT -SMOOTHBORE PEDIATRIC + 0,8 M LIMB - 481 401 BREATHING CIRCUIT- CORRUGATED IPPB WITH NEBULISER ADULT - 489 201 BREATHING CIRCUIT - SMOOTHBORE SINGLE WATER TRAP ADULT + 0,8 M LIMB + BREATHING BAG - 485 201 S BREATHING CIRCUIT - EXTENDABLE SINGLE WATER TRAP ADULT - 487 001 BREATHING CIRCUIT - EXTENDABLE SINGLE WATER TRAP PEDIATRIC + 1 M LIMB - 488 101 S BREATHING CIRCUIT - CORRUGATED DOUBLE WATER TRAP PEDIATRIC - 484 301 S BREATHING CIRCUIT - EXTENDABLE DOUBLE WATER TRAP ADULT + 1 M LIMB - 487 401 S ANESTHESIA CIRCUIT -CORRUGATED PEDIATRIC - 480 301 S BREATHING CIRCUIT-TRANSPORT VENTILATOR CIRCUIT WITH MANIFOLD ADULT - 489 292 S BREATHING CIRCUIT- (COAXIAL) CIRCUIT BASIC/ PEDIATRIC + 1M LIMB - 489 312 BREATHING CIRCUIT-CORRUGATED IPPB ADULT CLOSED SYSTEM - 489 231 BREATHING CIRCUIT - EXTENDABLE DOUBLE WATER TRAP PEDIATRIC - 488 301 BREATHING CIRCUIT- DOUBLE LINE TRANSPORT VENTILATOR CIRCUIT CORRUGATED ADULT - 489 286 BREATHING CIRCUIT-'T' TUBE CIRCUIT - 489 601 S BREATHING CIRCUIT - SMOOTHBORE DOUBLE WATER TRAP ADULT + 0,8 M LIMB + BREATHING BAG - 485 501 BREATHING CIRCUIT - SMOOTHBORE DOUBLE WATER TRAP ADULT - 485 301 S BREATHING CIRCUIT - SMOOTHBORE SINGLE WATER TRAP ADULT + 0,8 M LIMB + BREATHING BAG - 485 201 BREATHING CIRCUIT - EXTENDABLE DOUBLE WATER TRAP ADULT + 1 M LIMB + BREATHING BAG - 487 501 S BREATHING CIRCUIT- (COAXIAL) CIRCUIT BASIC/ PEDIATRIC + 1M LIMB + 2L BREATHING BAG - 489 313 S BREATHING CIRCUIT-SMOOTHBORE IPPB ADULT - 489 261 S BREATHING CIRCUIT-SMOOTHBORE IPPB PEDIATRIC CLOSED SYSTEM - 489 255 S BREATHING CIRCUIT - SMOOTHBORE SINGLE WATER TRAP PEDIATRIC + 0,8 M LIMB - 486 101 BREATHING CIRCUIT-EXTENDED IPPB ADULT CLOSED SYSTEM - 489 271 BREATHING CIRCUIT - EXTENDABLE SINGLE WATER TRAP ADULT - 487 001 S BREATHING CIRCUIT-CORRUGATED IPPB PEDIATRIC - 489 245 S BREATHING CIRCUIT- (COAXIAL) CIRCUIT BASIC/ PEDIATRIC + 1M LIMB - 489 312 S BREATHING CIRCUIT- DOUBLE LINE TRANSPORT VENTILATOR CIRCUIT EXTENDED ADULT - 489 288 S BREATHING CIRCUIT - SMOOTHBORE DOUBLE WATER TRAP PEDIATRIC + 0,8 M LIMB + BREATHING BAG - 486 501 BREATHING CIRCUIT - EXTENDABLE SINGLE WATER TRAP PEDIATRIC - 488 001 S BREATHING CIRCUIT - EXTENDABLE DOUBLE WATER TRAP PEDIATRIC + 1 M LIMB + BREATHING BAG - 488 501 BREATHING CIRCUIT - SMOOTHBORE SINGLE WATER TRAP PEDIATRIC + 0,8 M LIMB - 486 101 S BREATHING CIRCUIT - CORRUGATED SINGLE WATER TRAP PEDIATRIC - 484 001 BREATHING CIRCUIT - EXTENDABLE SINGLE WATER TRAP ADULT + 1 M LIMB + BREATHING BAG - 487 201 ANESTHESIA CIRCUIT - EXTENDABLE ADULT + 1 M LIMB + BREATHING BAG - 482 201 BREATHING CIRCUIT- CORRUGATED IPPB ADULT - 489 241 BREATHING CIRCUIT-CORRUGATED IPPB ADULT CLOSED SYSTEM - 489 231 S BREATHING CIRCUIT-EXTENDED IPPB PEDIATRIC CLOSED SYSTEM - 489 275 BREATHING CIRCUIT-CORRUGATED DOUBLE WATER TRAP INFANT - 484 611 BREATHING CIRCUIT - CORRUGATED SINGLE WATER TRAP ADULT + 0,8 M LIMB - 483 101 BREATHING CIRCUIT-CORRUGATED WATER TRAP HEATED WIRE PEDIATRIC - 489 021 BREATHING CIRCUIT - CORRUGATED SINGLE WATER TRAP ADULT - 483 001 S BREATHING CIRCUIT - EXTENDABLE DOUBLE WATER TRAP ADULT + 1 M LIMB + BREATHING BAG - 487 501 BREATHING CIRCUIT- DOUBLE LINE TRANSPORT VENTILATOR CIRCUIT CORRUGATED PEDIATRIC - 489 289 S BREATHING CIRCUIT - CORRUGATED SINGLE WATER TRAP PEDIATRIC + 0,8 M LIMB - 484 101 ANESTHESIA CIRCUIT -SMOOTHBORE ADULT + 0,8 M LIMB + BREATHING BAG - 481 201 S ANESTHESIA CIRCUIT - CORRUGATED ADULT + 0,8 M LIMB - 480 101 S BREATHING CIRCUIT- CORRUGATED HEATED WIRE PEDIATRIC - 489 051 BREATHING CIRCUIT - EXTENDABLE DOUBLE WATER TRAP ADULT - 487 301 ANESTHESIA CIRCUIT -CORRUGATED ADULT + 0,8 M LIMB + BREATHING BAG - 480 201 BREATHING CIRCUIT- DOUBLE LINE TRANSPORT VENTILATOR CIRCUIT SMOOTHBORE PEDIATRIC - 489 290 BREATHING CIRCUIT-TRANSPORT VENTILATOR CIRCUIT WITH MANIFOLD ADULT - 489 292 ANESTHESIA CIRCUIT - EXTENDABLE ADULT +1 M LIMB - 482 101 S ANESTHESIA CIRCUIT -SMOOTHBORE ADULT + 0,8 M LIMB + BREATHING BAG - 481 201 ANESTHESIA CIRCUIT - EXTENDABLE PEDIATRIC + 1 M LIMB + BREATHING BAG - 482 501 S BREATHING CIRCUIT- DOUBLE LINE TRANSPORT VENTILATOR CIRCUIT CORRUGATED ADULT - 489 286 S BREATHING CIRCUIT-SMOOTHBORE IPPB PEDIATRIC - 489 265 S ANESTHESIA CIRCUIT -EXTENDABLE ADULT - 482 001 BREATHING CIRCUIT- (COAXIAL) CIRCUIT BASIC/ ADULT+1M LIMB+2L BREATHING BAG - 489 303 S ANESTHESIA CIRCUIT -CORRUGATED PEDIATRIC + 0,8 M LIMB + BREATHING BAG - 480 501 BREATHING CIRCUIT-EXTENDED IPPB PEDIATRIC - 489 285 S BREATHING CIRCUIT - EXTENDABLE SINGLE WATER TRAP ADULT + 1 M LIMB - 487 101 BREATHING CIRCUIT - CORRUGATED DOUBLE WATER TRAP PEDIATRIC + 0,8 M LIMB - 484 401 BREATHING CIRCUIT - SMOOTHBORE DOUBLE WATER TRAP ADULT + 0,8 M LIMB + BREATHING BAG - 485 501 S BREATHING CIRCUIT - CORRUGATED DOUBLE WATER TRAP PEDIATRIC - 484 301 BREATHING CIRCUIT - CORRUGATED SINGLE WATER TRAP PEDIATRIC + 0,8 M LIMB + BREATHING BAG - 484 201 BREATHING CIRCUIT - SMOOTHBORE DOUBLE WATER TRAP PEDIATRIC - 486 301 BREATHING CIRCUIT - EXTENDABLE DOUBLE WATER TRAP PEDIATRIC + 1 M LIMB + BREATHING BAG - 488 501 S ANESTHESIA CIRCUIT - EXTENDABLE PEDIATRIC +1 M LIMB - 482 401 S BREATHING CIRCUIT-CORRUGATED WATER TRAP HEATED WIRE ADULT - 489 011 S ANESTHESIA CIRCUIT -EXTENDABLE ADULT - 482 001 S BREATHING CIRCUIT-SMOOTHBORE SINGLE WATER TRAP INFANT - 485 211 S BREATHING CIRCUIT-SMOOTHBORE IPPB ADULT - 489 261 BREATHING CIRCUIT - CORRUGATED DOUBLE WATER TRAP ADULT + 0,8 M LIMB + BREATHING BAG - 483 501 S BREATHING CIRCUIT-SMOOTHBORE IPPB ADULT CLOSED SYSTEM - 489 251 BREATHING CIRCUIT - SMOOTHBORE DOUBLE WATER TRAP PEDIATRIC + 0,8 M LIMB + BREATHING BAG - 486 501 S BREATHING CIRCUIT-CORRUGATED SINGLE WATER TRAP INFANT - 484 211 S BREATHING CIRCUIT - EXTENDABLE SINGLE WATER TRAP ADULT + 1 M LIMB - 487 101 S BREATHING CIRCUIT - CORRUGATED SINGLE WATER TRAP ADULT - 483 001 ANESTHESIA CIRCUIT -SMOOTHBORE ADULT + 0,8 M LIMB - 481 101 ANESTHESIA CIRCUIT -CORRUGATED PEDIATRIC - 480 301 BREATHING CIRCUIT- (COAXIAL) CIRCUIT BASIC/ ADULT+1M LIMB - 489 302 ANESTHESIA CIRCUIT -CORRUGATED ADULT - 480 001 S BREATHING CIRCUIT - CORRUGATED NEONATAL - 484 601 S BREATHING CIRCUIT - EXTENDABLE SINGLE WATER TRAP ADULT + 1 M LIMB + BREATHING BAG - 487 201 S BREATHING CIRCUIT- DOUBLE LINE TRANSPORT VENTILATOR CIRCUIT EXTENDED ADULT - 489 288 ANESTHESIA CIRCUIT -SMOOTHBORE ADULT + 0,8 M LIMB - 481 101 S ANESTHESIA CIRCUIT -CORRUGATED PEDIATRIC + 0,8 M LIMB - 480 401 BREATHING CIRCUIT - EXTENDABLE SINGLE WATER TRAP PEDIATRIC + 1 M LIMB + BREATHING BAG - 488 201 BREATHING CIRCUIT- (COAXIAL) CIRCUIT BASIC/ PEDIATRIC - 489 311 S BREATHING CIRCUIT- CORRUGATED HEATED WIRE PEDIATRIC - 489 051 S BREATHING CIRCUIT-CORRUGATED HEATED WIRE ADULT - 489 001 BREATHING CIRCUIT- DOUBLE LINE TRANSPORT VENTILATOR CIRCUIT CORRUGATED PEDIATRIC - 489 289 ANESTHESIA CIRCUIT - EXTENDABLE ADULT + 1 M LIMB + BREATHING BAG - 482 201 S BREATHING CIRCUIT - EXTENDABLE DOUBLE WATER TRAP PEDIATRIC + 1 M LIMB - 488 401 ANESTHESIA CIRCUIT -CORRUGATED PEDIATRIC + 0,8 M LIMB + BREATHING BAG - 480 501 S ANESTHESIA CIRCUIT -CORRUGATED ADULT + 0,8 M LIMB + BREATHING BAG - 480 201 S ANESTHESIA CIRCUIT - EXTENDABLE PEDIATRIC +1 M LIMB - 482 401 BREATHING CIRCUIT - EXTENDABLE DOUBLE WATER TRAP ADULT + 1 M LIMB - 487 401 BREATHING CIRCUIT- (COAXIAL) CIRCUIT BASIC/ ADULT - 489 301 S BREATHING CIRCUIT- DOUBLE LINE TRANSPORT VENTILATOR CIRCUIT SMOOTHBORE PEDIATRIC - 489 290 S BREATHING CIRCUIT- DOUBLE LINE TRANSPORT VENTILATOR CIRCUIT EXTENDED PEDIATRIC - 489 291 BREATHING CIRCUIT-SMOOTHBORE IPPB PEDIATRIC - 489 265 BREATHING CIRCUIT-'T' TUBE CIRCUIT - 489 601 BREATHING CIRCUIT - SMOOTHBORE SINGLE WATER TRAP ADULT - 485 001 BREATHING CIRCUIT - SMOOTHBORE DOUBLE WATER TRAP ADULT - 485 301 BREATHING CIRCUIT - CORRUGATED SINGLE WATER TRAP PEDIATRIC - 484 001 S BREATHING CIRCUIT - SMOOTHBORE SINGLE WATER TRAP ADULT + 0,8 M LIMB - 485 101 ANESTHESIA CIRCUIT -EXTENDABLE PEDIATRIC - 482 301 BREATHING CIRCUIT - SMOOTHBORE SINGLE WATER TRAP PEDIATRIC - 486 001 S BREATHING CIRCUIT-CORRUGATED IPPB PEDIATRIC - 489 245 BREATHING CIRCUIT-SMOOTHBORE IPPB PEDIATRIC CLOSED SYSTEM - 489 255 BREATHING CIRCUIT - EXTENDABLE DOUBLE WATER TRAP ADULT - 487 301 S BREATHING CIRCUIT - CORRUGATED SINGLE WATER TRAP ADULT + 0,8 M LIMB + BREATHING BAG - 483 201 BREATHING CIRCUIT - CORRUGATED SINGLE WATER TRAP PEDIATRIC + 0,8 M LIMB + BREATHING BAG - 484 201 S BREATHING CIRCUIT - EXTENDABLE DOUBLE WATER TRAP PEDIATRIC + 1 M LIMB - 488 401 S ANESTHESIA CIRCUIT -CORRUGATED ADULT - 480 001 BREATHING CIRCUIT - EXTENDABLE DOUBLE WATER TRAP PEDIATRIC - 488 301 S BREATHING CIRCUIT-SMOOTHBORE IPPB WITH NEBULISER ADULT - 489 221 BREATHING CIRCUIT - SMOOTHBORE DOUBLE WATER TRAP ADULT + 0,8 M LIMB - 485 401 BREATHING CIRCUIT - EXTENDABLE SINGLE WATER TRAP PEDIATRIC + 1 M LIMB - 488 101 ANESTHESIA CIRCUIT - EXTENDABLE ADULT +1 M LIMB - 482 101 BREATHING CIRCUIT - CORRUGATED DOUBLE WATER TRAP ADULT + 0,8 M LIMB + BREATHING BAG - 483 501 BREATHING CIRCUIT- DOUBLE LINE TRANSPORT VENTILATOR CIRCUIT SMOOTHBORE ADULT - 489 287 S BREATHING CIRCUIT- CORRUGATED HEATED WIRE INFANT - 489 061 S BREATHING CIRCUIT- (COAXIAL) CIRCUIT BASIC/ PEDIATRIC + 1M LIMB + 2L BREATHING BAG - 489 313 ANESTHESIA CIRCUIT -SMOOTHBORE PEDIATRIC + 0,8 M LIMB + BREATHING BAG - 481 501 ANESTHESIA CIRCUIT -SMOOTHBORE ADULT - 481 001 S BREATHING CIRCUIT-CORRUGATED DOUBLE WATER TRAP INFANT - 484 611 S ANESTHESIA CIRCUIT -EXTENDABLE PEDIATRIC - 482 301 S BREATHING CIRCUIT-CORRUGATED WATER TRAP HEATED WIRE ADULT - 489 011 NEBULIZER SET SINGLE CHAMBER - 130 121 NEBULIZER SET- MOUTHPIECE (HALF ELBOW) - 130 108 NEBULIZER SET WITH T PART AND VALVE - 130 205 NEBULIZER SET-PEDIATRIC (TURNING HEAD) - 130 057 NEBULIZER SET - 130 120 NEBULIZER SET-PEDIATRIC - 130 107 NEBULIZER SET-ADULT - 130 106 NEBULIZER SET-ADULT (TURNING HEAD) - 130 056 NEBULIZER SET- INFANT - 130 058 NEBULIZER SET WITH T PART - 130 109

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2021-03-23
FOC	Bag, Urine Collection, Newborn	Gastroenterology, Urology	Class 2	876.5250	2021-03-23
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2021-03-24
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	2021-04-28
EYK	Connector, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2023-07-18
FOG	Hood, Oxygen, Infant	Anesthesiology	Class 1	868.5700	2021-03-24
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2021-03-23
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-03-23
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2021-03-24
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2021-03-23
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2021-03-23
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2021-03-24
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2021-05-24
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2021-03-24
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2021-03-23
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2021-03-23
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2021-03-24
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2021-03-23
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2021-03-23

Official Correspondent

Cemile Hande TUNC

US Agent Details

Margarita Morales Business: Healthcare International Partners, LLC Email: maggie@hip-llc.com Phone: (786) 3602695

Related Public Records

Same Entity

Plasti-med Plastik Medikal Urunler San. ve Tic. Ltd. Sti.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K911329	C.R. Bard, Inc.	BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE	1991-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120

Similar Registrations

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3015168527	Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, CN
3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL
1225492	NextPhase Medical Devices LLC	ROCHESTER, NH, US
3006547005	NINGBO BESMED MEDICAL EQUIPMENT CORP.	NINGBO Zhejiang, CN
3033959233	Jaeger Medical America Inc.	Moreno Valley, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018762668. Last updated year: 2026. Please use registration number 3018762668 when referencing this establishment in official correspondence.