Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006783791

FEI Number

3006783791

Entity Name

GaleMed (Xiamen) Co., Ltd.

City/State/Country

XIAMEN Fujian, CN

Establishment Address

Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39, Section 3, Haijing East Road, 361026 Fujian Province, China, XIAMEN Fujian 361026, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GaleMed Corporation (Owner Number: 8043316)

Owner / Operator Contact Address

87, LI-GONG 2ND RD.,, Wu-jia, TW-ILA 268, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EXHALOMETER GaleMed Large Volume Nebulizer Neb-Easy Nebulizer GALEMED NEBULIZER SET GALEMED LARGE VOLUME RF1 Nebulizer w/Valve T Kit, 22F, 22M RF1 Nebulizer w/Valve T Kit, 22M, 22M Neb.Easy Nebulizer w/Mouth Piece, Tube Neb.Easy AM-1 Mask, Infant w/Tube Neb.Easy AM-1 Mask, Adult w/Tube RF1 Nebulizer w/ATV, 1.6M Tube Neb.Easy AM-1 Mask, Child w/Tube Bravo II Bravo Disposable Tail-End Valve VentStar Resuscitaire CEU Galemed Gas sampling line Gas Sampling Line, 300cm, R1 Connector Sylent Sylent NE water trap Reusable water trap Water trap set Hybrid Complete System Dispo-BAG Manual Resuscitation Bag Disposable PEEP Valve DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve Dispo-Bag Manual Resuscitator Adj PEEP Valve, 7.5cmH2O, 22F PEEP Valve, 5~20 cmH2O, 30F PEEP Valve, 2.5~10cmH2O, 30F DispoBag, Adult w/Pop-Off, Mask Adj. PEEP Valve, 5~20cmH2O, 22M Disposable Peep Valve 10cmH O, 30mmID Yellow PEEP Valve, 5~20cmH2O, 22F Disposable Peep Valve 7.5cmH O, 30mmID Green Disposable Peep Valve 5cmH O, 30mmID Blue Latex-Free Breathing Bag 2L Latex-Free Breathing Bag 2L Latex-Free Breathing Bag 3L Latex-Free Breathing breathing bag Silicone Breathing Bag Latex Breathing Bag VentStar Bag Set 120 2L NON-LATEX BREATHING BAG ID Bag Set 150 ID Breathing Bag Set Silicone Breathing Bag 2L w/loop end Latex-Free Breathing Bag 3L VentStar Bag Set Latex-Free Breathing Bag 1L VentStar breathing bag Set 150 Silicone Breathing Bag, 3L Latex-Free Breathing Bag 1L Silicone Breathing Bag, 2L Latex-Free Breathing Bag 0.5L Silicone Breathing Bag, 0.5L Silicone Breathing Bag, 1L Latex-Free Breathing Bag 0.5L PEEP valve Humidification Chamber Disposable Clip, Nose EMST75 Lite Respiratory Trainer Aircushion mask Aircushion mask with hook ring SURE SEAL ANESTHETIC MASK Airlift Resuscitator 1ST RESPONSE INFANT MANUAL RESUSCITATOR 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR Ventilator, emergency, manual(resus Nasal oxygen cannula Oxi.Plus Nasal Cannula Set, #0 Oxygen Conserving Cannula Softip-3 Nasal Cannula, Child C22 Star Lumen Tubing, 1000cm ADULT SOFT NASAL CANNULA WITH TUBING NHF Prong Kit, #3 ADULT NASAL CANNULA W/O TUBING Flow Indicator w/tubing, 160cm Oxi.Plus Nasal Cannula Set, #3 C22 Star Lumen Tubing, 200cm, 6M NHF Prong Kit, #4 Auto Chamber, Infant NEONATE SOFT NASAL CANNULA WITH TUBING Softip-1 Nasal Cannula, Infant Softip-3 Nasal Cannula, Adult Softip-3 Nasal Cannula, Infant Oxi.Plus Nasal Cannula Set, #2 ADULT NASAL CANNULA WITH TUBING Softip-1 Nasal Cannula, Adult Oxi.Plus Nasal Cannula Set, #1 PAEDIATRIC SOFT NASAL CANNULA WITH TUBING NHF Prong Kit, #2 Softip-1 Nasal Cannula, Child C23 Star Lumen Tubing, 200cm, 6M Flare Nasal Cannula, Adult Flow Indicator w/tubing, 200cm Swivel Anesthesia Circuit, Adult Manifold, 3 Way, PSF Hytrel Ckt, Child, 120cm w/Water Trap CV-3 Manifold, L22M Disposable respiratory circuit Disposable anesthesia circuit Single limb manifold EVA Circuit, Adult, 180cm EVA Single Limb Circuit, 165cm EVA Circuit, Adult, 180cm w/Mask #4 Disposable Anesthesia Circuit, Coaxial Circuit, Adult, 180cm EVA Single Limb Circuit, 165cm w/WT VENTILATOR CIRCUIT Anesthesia set Basic, latexfree VentStar Anaesthesia w/o LuerL Reusable Breathing Circuit, Single Limb Anesth. Set Basic Latexfr.,US Manifold, 2 way, PSF VentStar Basic P 150 w/o LuerL Vent Set Basic Silicone J-Circuit, Adult Silicone Single Limb Circuit, Adult Standard Coaxial Circuit (150cm tubing), Adult Hytrel Ckt, Adult, 120cm w/2 Water Trap EVA Circuit, Adult, 1.5m Theta Circuit, 150cm Anesthesia Circuit, Adult, 1.5m Theta Anesthesia Circuit, 180 cm, Adult HBC Adult Breathing Circuit Sil.Plus Circuit, Adult w/2 Water Trap Coaxial Circuit, Adult, 1.8m Anesthesia Circuit, Adult, 1.8m Standard Coaxial Circuit (180cm tubing), Adult Durable Silicone Breathing Circuit with water trap, Adult VentStar Anesth (P) w/o. LuerL Theta Circuit, 180cm Disposable anesthesia circuit 1.5m (Adult, latex-free breathing bag 3L) ECO Anesthesia Circuit, Adult Sil.Plus Circuit, Child w/2 Water Trap Coaxial Circuit, Adult, 1.5m L Connector, 22F, 22/15mm, PC Disposable Tail Valve 12M, 15M Disposable Respiratiory Circuit, Single Limb Vent Set Flex Anesthesia Circuit, Adult, 1.2m Anesthesia set Flex, latexfree Disposable anesthesia circuit 1.5m (Child, latex-free breathing bag 1L) Hytrel Circuit, Adult w/Water Trap Hytrel Ckt, Child, 120cm w/2 Water Trap Utopia AV Full face mask Silicone breathing hose, adult, 1.5m Hydrophobic filter for pressure tubing line Gas Sampling Line, Adult 2.5 m Silicone breathing hose, adult, 0.45m Silicone breathing hose Disposable corrugate tube Reusable swivel flex tube Aerosol Tube Assembly Carrier Gas Tube Assembly Oxygen Line Accessory Gas Sampling Line, 50cm, 4M, 4M Pressure line for Ckt, 180cm, L6F, 4.3M Filter, Hydrophobic 4F, 4M Gas Sampling Set (Sidestream) Gas Sampling Line, 300cm, 4M GALEMED TUBING Hytrel Hose, 22F/19T, 110cm, Blue Hytrel Hose, 22F/19T, 60cm, Blue Hytrel Hose, 15F/15T, 60cm, Blue Sil.Flex Hose, 22F, 35cm Silicone Hose, 22F, 20cm Silicone breathing hose, child/infant, 1.5m EVA corraguate tube, 1.8m, bue Gas Sampling Line, Neonate 2.5 m EVA SB Hose, 22F, 180cm Nihon Kohden Exhalation Port Aircushion mask,size 4,adult Aircushion mask, size 2, Child NASAL CPAP MASK Aircushion mask, Size 5, Adult Large Economy reusable mask, #5, adult large Silicone mask, size 2, child Aircushion mask, size 1, infant large Venturi, 31% O2, 22M, White Venturi, 50% O2, 22M, Orange OM-1 Mask, Infant w/Tubing OM-2 HiO2 Mask, Child AM-3 Adj-Venturi Mask, Child w/Tube Venturi, 40% O2/8LPM, 22M, Red Adj Venturi (LAV) Adaptor, 22F Venturi, 35% O2, 22M, Green LAV Venturi Mask Kit, Adult M1 HiO2 Mask, L AM-2 HiO2 Mask, Adult TM-1 Trachea Mask, Adult w/Tubing Venturi, 50% O2, 22F, Orange OM-2 Hi-O2 Mask, Adult AM-2 Oxygen Mask, Adult OM-3 HiO2 Mask, Child w/Tubing, PVC Bag OM-1 HiO2 Mask, Infant w/Tubing M1 Oxygen Mask, M OM-5 face Tent w/Tubing AM-3 Venturi Mask, Adult Venturi, 24% O2, 22M, Blue OM-1 Mask, Adult OM-2 PR-Mask, Adult w/Tubing Venturi, 28% O2, 22M, Yellow GALEMED MASK AM-2 Aerosol Mask, Adult Silicone mask, size 0, infant AM-2 Aerosol Mask, Child Economy reusable mask, #3, child large Aircushion mask, size 0, infant Silicone mask, size 1, infant large Economy reusable mask, #4, adult CPAP Face Mask Set w/Hose, S NIV Mask, S EVA SB Hose, 19f, 180cm w/Cuff, 22F*2 NIV Mask CPAP Full Mask CPAP/VPAP Mask CPAP Face Mask Set w/Hose, M CPAP Face Mask Set w/Hose, L NIV Mask, L NIV Mask, M VentStar Oxylog 3000F (P) 190 Venti.Plus Disposable Pressure Manometer Disposable Pressure Manometer Dual Limb Circuit for Pneupac Ventilators Single Limb Circuit for Pneupac Ventilators Dual Limb Circuit for Pneupac® babyPACTM Ventilators Single Limb Circuit for Pneupac® DEMAND type Ventilators, with PEEP Valve and Pressure Monitoring Line with In-Line Filt Single Limb Circuit for Pneupac® paraPAC plusTM Ventilator with 0-20 cmH2O PEEP Valve and Internal Pressure Monitoring Single Limb Circuit for Pneupac® DEMAND type Ventilators, with PEEP Valve Single Limb Circuit for Pneupac® paraPAC plusTM Ventilators with Internal Pressure Monitoring Line with In-Line Filter Single Limb Circuit for Pneupac® DEMAND type Ventilators Mouth Piece, 13M Connector, 15M, 5F, PP Connector, 22M, 22/15mm, PP Reusable wye connector Reusable elbow connector Reusable straight connector Disposable swivel wye connector In-Line NebTee with Valve Disposable elbow connector Disposable straight connector Disposable wye connector SY Connector , 15F, 15B, 7.6F Connector, 22F, 10/7.6mm, PSF S connector, 22/15mm, 15M, 4.3F DS-L Connector w/Suction Port, 15F, 15M, Y Connector, 15F, 10M, 7.6F, 6M L Connector, 22F, 22/15mm PSF Cap w/strap 7.6F, 6F Connector, 22/15mm, 22/15mm SP Connector, 22F, 22/15mm, 7.6F Y Connector, 15F, 10M, 7.6F L Connector, 22M, 22/15mm, PSF Flow Meter Adaptor, Green MDI Adaptor, 15F, 15M T Connector, 7.6F, 7.6/4.3mm, 7.6M CPAP Exhale Vent, 22M, 22M L Connector , 22/15mm, 15M, 7.6F DS-L Connector, 15F, 15M w/Seal Cap Flow Meter Adaptor, 22M/15F, Aluminum Connector, 22M, 22/19mm, PP Connector, 22F, 22F, PC SY Connector, 22B, L4B Swivel Connector w/Clamp Cap, 15F, Yellow Connector, 22F, 15M, K Resin L Connector, 7.6M, 4B, PSF, Amber L Connector, 22F, 22/15mm, PC T Connector, 15F, 22/18mm, 15M SP Connector, 22F, 22/15mm, 6M SP Connector, 22F, 22/15mm, Luer, PC Connector, 22F, 22F, PSF T Connector,10/7.6mm,10/7.6mm,10/7.6mm L Connector , 22/15mm, 15M, 6M Flow Meter Adaptor, White SP Connector, 22F, 22/15mm, 7.6F, PSF Y Connector, 22/15mm, 22M, 7.6F In-Line Valve Connector, 22F, 22M Connector, 15M, 10F Y Connector, 15F, 10M, PSF Connector, 15F, 15M, PP L Connector, 22/15mm, 15M, Luer T Connector , 22M, 22/15mm, 22M, 7.6F T Connector, 22M, 22/18mm, 22M Y Connector w/Luer, 15F, 10M Connector, 30F, 22M, PP DS-L Connector, 22/15mm, 15M Y Connector w/port , 22/15mm, 22M T Adaptor for Jackson Rees Circuit Y Connector, 15F, 15Mx2, 4.3F, PC Connector, 22/15mm, 15M, 7.6F Connector, 10F/10F, Silicone L Connector, 15F, 15M, PSF, Amber L connector, 22/15mm, 15M, 7.6F SP Connector, 22F, 22/15mm, 6M, PC Y Connector, 15F, 15M, 7.6F Cap w/Strap 4.3M, Green Bear Pacifier Adaptor Y Connector, 22F w/7.6F SP Connector, 22/15mm, 10F, 6M Connector, 7.6M, Luer, PSF Connector, 22F, 15M, PC Valve Tee, 22F, 18F, 22/15mm Y Connector, 15F, 22M Connector, 22F, 22F, K Resin Y Connector, 22/15mm, 22M Adaptor for O2 Mask, 18M, 6M Y Connector, 22/15mm, 22M, 4.3F T connector w/luer, 22M, 22/15mm, 22M Catheter Mount, 20cm, 22/15mm, 15M Connector, 22/15mm, 6M, PP VENTI.PLUS SINGLE POLE CLAMP SP connector, 22/15mm, 15M, 6M(X) Neonate Connector Kit Y Connector, 15F, 10M Connector, 22F, 22/15mm, PC Connector, 10F, 10/7.6mm, K Resin Connector, 6M, 4M, K Resin CV-5 manifold 22F/19M,22F/15M,7.5M,4.3M T Connector, 22M, 22/15mm, 22M Y connector, 15F, 10Mx2, 6M AIRWAY CONNECTOR C2 Tubing Adaptor, 6F, PVC MDI L-Adaptor, 22M/15F, 15M Adaptor for HiO2 Mask w/Valve DS-L Connector w/Suction Port, 15M Rescu-7 Diverter, 30/26mm Connector, 5M, 5M, K Resin Connector, 15F, 5.5F, PP SP Connector, 22/15mm, 22/15mm, 6M Cap, 22F, Green Cap w/Strap, 4M, Silicone Venti.Plus Dual Pole Clamp T Connector w/Luer, 22F, 10/7.6mm Cap w/Strap, for 7.6F Taper Port Connector, 10/7.6mm, 10f, PSF Y connector, 22Mx2, 22/15 (X) T Connector , 22F, 22/18mm, 22M, 6M Connector, 22/15mm, 15M, PSF Connector, 22F, 22/15mm, PSF ADU Connector Valve Tee, 15F, 18F, 15M T Connector w/Luer, 22M, 22/15mm, 22M Valve Tee, 22M, 18F 22M SP Connector, 22/15mm, 15M, 6M Connector, 22/15mm, 22/15mm PSF L Connector, 4.3M, 4M In-Line Valve Connector, 22M, 22F Connector, 22F, 15F, PP T Connector, 22F, 22/18mm, 22M, PS SP Connector, 22/15mm, 15M, 7.6F SP Connector, 22F, 22M, 8.5M Connector, 15M, 4.5F, PP SP Connector, 22F, 10/7.6mm, Luer Connector, 32M, 22M, PP T Connector, 22F, 22/18mm, 22M MR-100 Diverter, 30/26mm L Connector, 22M w/Luer Port Neonate Straight connector, 7.6/10mm L Connector, 7.6M, 6M, PSF, Amber T Connector, 10F, 4.3F, 10/7.6mm SY Connector, 15F, 10M, 7.6F Connector, 15M, 6M, PP Reusable wye connector, 22M Straight Connector 22/15mm, 15M, Luer Reusable elbow connector, 22M/15F, 22F Valves Aerosol Tee Adaptor HME Disposable Adjustable PEEP Valve MR Conditional PEEP Valve, 5-20cmH2O, 30F w/adapter BERMAN AIRWAY Guedel Airway 8cm, Green COLOR CODED AIRWAYS BERMAN 7CM DRAWING REV1 Guedel Airway 9cm, Yellow Berman Airway 9cm BERMAN 5CM BERMAN 8CM DRAWING REV.A BERMAN 6CM DRAWING REV1 EMST150 expiratory muscle device Bravo Trainer, Blue FLOWREST Universal connector C22 Tubing, 200cm, 6/4mm Fits-all Oxygen Tubing Connector Swivel Oxygen Tubing Connector, Male/Female C22 Star Lumen Tubing, 200cm, 6M Swivel Oxygen Tubing Connector, Male/Male Disposable Oxygen Tubing R2 Star Lumen Tubing, 200cm, 6M 4.3mm Luer Cap Thread Type Color: Blue VentStar Oxylog 1000 180 Silicone mask Reusable mask Economy reusable mask Aircushion Mask Size 5 SURE SEAL® Air Cushion Mask, w/ Valve, Ped/Toddler SURE SEAL® Air Cushion Mask, w/ Valve, Infant Air-SoftTM Mask Size 1, Infant Large, w/Valve Airsoft Mask, #5 w/Valve SURE SEAL® Air Cushion Mask, Neonate Air-SoftTM Mask Size 3, Child Large, w/Valve AirLifeTM AirLife Disposable Face Mask Neonate Airsoft Mask, #1 Air-SoftTM Mask Size 5, Adult Large, w/Valve SURE SEAL® Air Cushion Mask, w/ Valve, Neonate SURE SEAL ANESTHETIC MASK Endo Mask, L w/Harness Hook ring for LiteStar masks with 15mm connector Air-SoftTM Mask Size 4, Adult, w/Valve Mask LiteStar4 w/o hook SURE SEAL® Air Cushion Mask, Infant RESUSCITATION MASK LARGE ADULT Mask LiteStar1 w/o hook Headgear disp.,soft rub.,large SURE SEAL® Air Cushion Mask, Ped/Toddler SURE SEAL® Air Cushion Mask, Med Adult SURE SEAL® Air Cushion Mask, w/ Valve, Sm Adult/Youth Airsoft Mask, #3 w/Valve Airsoft Mask, #5 RESUSCITATION MASK LARGE CHILD SURE SEAL® Air Cushion Mask, w/ Valve, Large Adult Airsoft Mask, #4 w/Valve RESUSCITATION MASK LARGE INFANT Airsoft Mask, #2 w/Valve Mask LiteStar3 w/o hook Rendell Baker Silicone Mask, #0 SURE SEAL® Air Cushion Mask, Large Adult Airsoft Mask, #4 Headgear disp.,soft fabric,la. Headgear disp.,soft farbic,sm. Airsoft Mask, #2 Headgear disp.,soft rub.,small Airsoft Mask, #1 w/Valve SURE SEAL® Air Cushion Mask, w/ Valve, Med Adult Aircushion Mask Size 3 AIR SOFT MASK, SIZE 1 Airsoft Mask, #3 Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #4 Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #1 Airsoft Mask, #6 w/Valve Mask LiteStar2 w/o hook Airsoft Mask, #0 w/Valve AirLifeTM AirLife Disposable Face Mask Pediatric SURE SEAL® Air Cushion Mask, Sm Adult/Youth Air-SoftTM Mask Size 2, Child, w/Valve Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #3 Airsoft Mask, #0 Mask LiteStar6 w/o hook RESUSCITATION MASK SMALL ADULT Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #2 Ambu Open Cuff Silicone Face Mask Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #0 Mask LiteStar5 w/o hook Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #5 1" Response Manual Resuscitator, Adult Ventilator, emergency, manual(resus 1" Response Pediatric Manual Resuscitator, Child large Ventilator, emergency, manual(resus PocketPak Mouth-to-Mask Resuscitator HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR Hybrid AV Interface

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2012-12-17
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2012-12-17
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-03-14
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-12-10
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2015-05-21
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2024-08-01
KGK	Gas, Collecting Vessel	Anesthesiology	Class 1	868.1575	2015-06-02
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-12-10
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2013-07-31
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-12-10
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2008-11-05
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-11-05
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2013-07-31
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2011-09-22
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2013-12-10
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2011-02-09
PKS	Exerciser, Non-Measuring For Stroke Rehabilitation	Physical Medicine	Class 1	890.5370	2023-05-13
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2007-03-14
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2013-10-31
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-03-03
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2011-09-06
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2007-03-14
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-12-10
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2007-03-14
BXO	Transducer, Gas Pressure	Anesthesiology	Class 1	868.2900	2015-07-07
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2024-08-29
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2007-03-14
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2007-12-19
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-07-31
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2010-12-06
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2015-01-26
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2015-01-26
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2025-12-17
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2007-03-14
OEV	Cardiopulmonary Resuscitation Aid Kit	Anesthesiology	Class 2	868.5915	2013-11-15
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2012-01-10
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2014-04-28
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2007-03-14
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2023-05-13
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2013-07-24
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2016-02-25
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-07-31
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2004-09-15
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-03-03
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-03-03
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2013-12-10
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2012-12-17
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

Matt Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076060

Related Public Records

Same Entity

GaleMed Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011659673	GALEMED LIMITED TAIPEI BRANCH	Taipei, TW
8043316	GALEMED CORP.	WU-JIA Yilan, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006783791. Last updated year: 2026. Please use registration number 3006783791 when referencing this establishment in official correspondence.