PRECISION FLUIDICS DIVISION PARKER HANNIFIN CORP.

FDA Device Registration & Listing · HATFIELD, PA, US · Registration 2518157

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2518157
FEI Number
2518157
Entity Name
PRECISION FLUIDICS DIVISION PARKER HANNIFIN CORP.
City/State/Country
HATFIELD, PA, US
Establishment Address
245 Township Line Rd, HATFIELD, PA 19440, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
PRECISION FLUIDICS DIVISION PARKER HANNIFIN CORP. (Owner Number: 9915034)
Owner / Operator Contact Address
245 Township Line Road, --, Hatfield, PA 19440, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Porter MXR-D – 4065D – MXR ,DIG.DISP,FLUSHMT,UNIVFTG/R MXR-D, Digital Flushmount Flowmeter Vacuum Controllers – 5501-RK – PORTER/BROWN VACUUM CONTROL KT / Porter In-Line Vacuum Control Block Medical Face Mask – SACA120 – SM ADLT FULL FCMSK BRTHNG CRCT / Facemask Small Medical Face Mask – DMC-PEDO – MASK,FLEX,ANES,SM CHILD,SIZE 3 / Disposable Mask Pedo Medical Face Mask – 93316427 – FACEMASK,SIZE#3,ADULT / Adult Full Face Mask Medical Face Mask – PDCA130 – PEDI FULL FCMSK BREATHING CRCT / Facemask Pediatric Medical Face Mask – 1550 – CLEAR MASK, CHILD / Porter Face Mask, Pediatric Medical Face Mask – YMCA140 – YTH MED FULL FCMSK BRTHNG CRCT / Facemask Youth Medical Face Mask – DMC-SMALL – MASK,FLEX,ANES,SM ADULT,SIZE 4 / Disposable Mask Small Medical Face Mask – DMC-MEDIUM – MASK,FLEX,ANES,ADLT,SIZE 5 / Porter Disposable Mask Medium Medical Face Mask – 93316426 – FACEMASK,SIZE#2,CHILD / Pediatric Full Face Mask Medical Face Mask – 1575-1 – FACEMASK, SIZE#3, ADULT / Porter Face Mask, Adult Medical Face Mask – DMC-LARGE – MASK,FLEX,ANES,ADLT LRG,SIZE 6 / Porter Disposable Mask Large Vacuum Controller – 5300SCAV – NITRONOX SCAVENGER / Nitronox Scavenger Demand System – NOX-5300 – NITRONOX SCAVENGER / NITRONOX SCAVENGER used with NOX-5300H Vacuum Controller – 5300SCAVD – NITRONOX SCAVENGER HD / Nitornox Scavenger HD Vacuum Controller – 5300SCAV-2 – NITRONOX SCAVENGER,2 CYL.CART / Nitronox Scavenger Cart Mount Vacuum Controller – 5300SCAVD-2 – NITRNX SCAVENGER HD,2 CYL.CART / Nitronox Scavenger HD Cart Mount Vacuum Controller – 5300WSCAV – NITRONOX SCAVENGER,WALL MOUNT / Nitronox Scavenger, Wall Mount Vacuum Controller – 5300WSCAVD – NITRONOX SCAVENGER,WALL MNT HD / Nitronox Scavenger HD Wall Mount Vacuum Controller – SENTRYSCAV – SENTRY SEDATE SCAVENGER KIT / Sentry Sedate, Scavenger Sentry Sedate – B-5700-000 – SCAVENGER SUB-ASSY,SEN SEDATE / Sentry Sedate, Scavenger Matrx Nasal Hoods – 91316469 – NASAL HOOD,MED,STRAWBERRY,24CT / Matrx Disposable DynoMite Nasal Hood Strawberry Medium Porter Nasal Hoods – 5054D – HOOD ASSY,PEDO,ONE LINER / Porter Pediatric Double Mask Hood Kit w/ 1 Inner Mask Liner Matrx Nasal Hoods – 91316521 – CNSTR HOOD,MED,ORNG 24CT / Matrx Disposable DynoMite Nasal Hood Orange Medium -DynoMite Matrx Nasal Hoods – 91316491 – CNSTR HOOD,LGE,ORANGE 24 CT R / Matrx Disposable DynoMite Nasal Hood Orange Large-DynoM Matrx Breathing Circuits – 91515194 – MATRX SCAV,SM HOOD,SHUTOFF VAL / Matrx Scavenger - Pediatric Assemblies Only Porter Breathing Circuits – 5155-3 – PORTER/BRN ADULT RG ASSY ONLY / Porter Adult Breathing Circuit – No Vacuum Control Matrx Nasal Hoods – 91316523 – CNSTR HOOD,MED,PLAIN,24 CT R / Matrx Disposable DynoMite Nasal Hood Plain Medium -Dyno Matrx Nasal Hoods – 91316515 – NASAL HOOD,LGE,ASSORTED 12 CT / Matrx Disposable DynoMite Nasal Hood Assorted Scents Lar Matrx Nasal Hoods – 91515094 – REPL SMALL NASAL HOOD / Matrx Reusable Nasal Hood, Pediatric Matrx Nasal Hoods – 91316478 – NASAL HOOD,LGE,VANILLA,24CT R / Matrx Disposable DynoMite Nasal Hood Vanilla Large -Dyn Matrx Breathing Circuits – 82501 – LG MATRX SCAV W/SCV, 3L BAG / Matrx Scavenger - W/3-Liter Breathing Bag and Scavenge Porter Nasal Hoods – 5053AD144 – DISPOSABLE LINER, ADULT, BOX / Porter Adult Disposable Inner Mask Liners (144 Pack) Matrx Nasal Hoods – 91316516 – NASAL HOOD,VAR,ASSORTED 12 CT / Matrx Disposable DynoMite Nasal Hood Assorted Scents Var Matrx Nasal Hoods – 91316511 – NASAL HOOD,LGE,STRAWBERRY 12CT / Matrx Disposable DynoMite Nasal Hood Strawberry Large - Matrx Nasal Hoods – 91316482 – CNSTR HOOD,SM,BUBBLE GUM 24 R / Matrx Disposable DynoMite Nasal Hood Bubble Gum Small - Porter Nasal Hoods – 5053AD12 – DISPOSABLE LINER, ADULT, BAG / Porter Adult Disposable Inner Mask Liners (12 Pack) Matrx Nasal Hoods – 91316494 – CNSTR HOOD,LGE,ASSORTED 24CT R / Matrx Disposable DynoMite Nasal Hood Assorted Scents La Matrx Nasal Hoods – 91316499 – NASAL HOOD,SM,VANILLA 12 CT / Matrx Disposable DynoMite Nasal Hood Vanilla Small -DynoMi Matrx Breathing Circuits – 82506 – SM MATRX SCAVENGER, 3L BAG / Matrx Scavenger Pediatric - W/3-Liter Breathing Bag Matrx Nasal Hoods – 91316514 – NASAL HOOD,LGE,PLAIN, 12 CT / Matrx Disposable DynoMite Nasal Hood Plain Large -DynoMite Matrx Nasal Hoods – 91316498 – NASAL HOOD,SM,ORANGE 12 CT / Matrx Disposable DynoMite Nasal Hood Orange Small -DynoMite Porter Nasal Hoods – 5053AD12C – DISP LINER,ADULT,BAG,CITRUS / Porter Adult Disposable Inner Mask Liners – Citrus (12 P Matrx Breathing Circuits – 91515189 – MATRX SCAV,W/MED HOOD(WO/SHUTO / Matrx Scavenger Medium without Shut-off Valve Matrx Nasal Hoods – 91316473 – NASAL HOOD,MED,ASSORTED,24CT R Matrx Disposable DynoMite Nasal Hood Assorted Scents Medi Matrx Nasal Hoods – 91316486 – CNSTR HOOD,SM,PLAIN 24 CT R / Matrx Disposable DynoMite Nasal Hood Plain Small -DynoM Matrx Nasal Hoods – 91316504 – NASAL HOOD,MED,STRAWBERRY 12CT / Matrx Disposable DynoMite Nasal Hood Strawberry Medium Matrx Nasal Hoods – 91316497 – NASAL HOOD,SM,STRAWBERRY 12 CT / Matrx Disposable DynoMite Nasal Hood Strawberry Small - Matrx Nasal Hoods – 91316479 – NASAL HOOD,LGE,PLAIN,24CT R / Matrx Disposable DynoMite Nasal Hood Plain Large -DynoM Porter Nasal Hoods – 5054-1 – ADULT MASK LINERS 3/PKG / Porter Adult Inner Mask Liners (3 Pack) Matrx Nasal Hoods – 91316501 – NASAL HOOD,SM,ASSORTED 12 CT / Matrx Disposable DynoMite Nasal Hood Assorted Scents Smal Matrx Nasal Hoods – 91316470 – NASAL HOOD,MED,ORANGE,24CT R / Matrx Disposable DynoMite Nasal Hood Orange Medium -DynoM Matrx Nasal Hoods – 91316484 – CNSTR HOOD,SM,ORANGE,24 CT R / Matrx Disposable DynoMite Nasal Hood Orange Small -Dyno Porter Nasal Hoods – 5053AD144C – DISP LINER,ADULT,BOX,CITRUS / Porter Adult Disposable Inner Mask Liners – Citrus (144 Matrx Breathing Circuits – 82502 – MED MATRX SCAV W/SCV, 3L BAG / Matrx Scavenger - W/3-Liter Breathing Bag and Scavenge Porter Nasal Hoods – 5054-2 – PEDO MASK LINERS 3/PKG /Porter Pediatric Inner Mask Liners (3 Pack) Matrx Nasal Hoods – 91316481 – NASAL HOOD,VAR,ASSORTED 24CT R / Matrx Disposable DynoMite Nasal Hood Assorted Scents Va Matrx Nasal Hoods – 91316476 – NASAL HOOD,LGE,STRAWBERRY,24CT / Matrx Disposable DynoMite Nasal Hood Strawberry Large - Matrx Nasal Hoods – 91316496 – NASAL HOOD,SM,BUBBLEGUM, 12 CT / Matrx Disposable DynoMite Nasal Hood Bubble Gum Small - Matrx Nasal Hoods – 91316505 – NASAL HOOD,MED,ORANGE 12 CT / Matrx Disposable DynoMite Nasal Hood Orange Medium -DynoMi Matrx Breathing Circuits – 91515190 – MATRX SCAV,W/SM HOOD(WO/SHUTOF / Matrx Scavenger Pediatric without Shut-off Valve Matrx Nasal Hoods – 91316480 – NASAL HOOD,LGE,ASSORTED,24CT R / Matrx Disposable DynoMite Nasal Hood Assorted Scents La Matrx Nasal Hoods – 91316495 – CNSTR HOOD,VAR,ASSORTED 24CT R / Matrx Disposable DynoMite Nasal Hood Assorted Scents Var Porter Breathing Circuits – 5155-1 – PORTER/BRN ADULT RG ASSY W/VB / Porter Adult Breathing Circuit w/ In-Line Vacuum C Matrx Nasal Hoods – 91316466 – NASAL HOOD,SM,ASSORTED,24CT R Matrx Disposable DynoMite Nasal Hood Assorted Scents Smal Matrx Nasal Hoods – 91316468 – NASAL HOOD,MED,BUBBLEGUM 24 R / Matrx Disposable DynoMite Nasal Hood Bubble Gum Medium Matrx Breathing Circuits – 82505 – MED MATRX SCAVENGER, 3L BAG / Matrx Scavenger Medium - W/3-Liter Breathing Bag Matrx Nasal Hoods – 91515096 – REPL LARGE NASAL HOOD / Matrx Reusable Nasal Hood, Large Porter Nasal Hoods – 5054B – HOOD ASSY, PEDO/ Porter Pediatric Double Mask Hood Kit w/ 3 Inner Mask Liners Matrx Nasal Hoods – 91316522 – CNSTR HOOD,MED,VANILLA 24CT R / Matrx Disposable DynoMite Nasal Hood Vanilla Medium- Dy Matrx Nasal Hoods – 91316471 – NASAL HOOD,MED,VANILLA,24CT R / Matrx Disposable DynoMite Nasal Hood Vanilla Medium -Dy Matrx Breathing Circuits – 91515193 – MATRX SCAV,MED HOOD,SHUTOFF VA / Matrx Scavenger - Medium Assemblies Only Matrx Nasal Hoods – 91316506 – NASAL HOOD,MED,VANILLA 12 CT / Matrx Disposable DynoMite Nasal Hood Vanilla Medium - Dyn Matrx Breathing Circuits – 91515188 – MATRX SCAV,W/LG HOOD(WO/SUTOFF / Matrx Scavenger Large without Shut-off Valve Porter Breathing Circuits - 91525191 – ORAL SURGERY Y SEL VLV W/RBR G / Directional Valve Package Matrx Nasal Hoods – 91316477 – NASAL HOOD,LGE,ORANGE,24CT R / Matrx Disposable DynoMite Nasal Hood Orange Large -Dyno Matrx Nasal Hoods – 91316524 – CNSTR HOOD,MED,ASSORTED24 CT R / Matrx Disposable DynoMite Nasal Hood Assorted Scents Me Matrx Nasal Hoods – 91316472 – NASAL HOOD,MED,PLAIN,24CT R / Matrx Disposable DynoMite Nasal Hood Plain Medium -Dyno Matrx Nasal Hoods – 91316490 – CNSTR HOOD,LGE,STRAWBERRY 24 R Matrx Disposable DynoMite Nasal Hood Strawberry Large -Dy Matrx Nasal Hoods – 91316520 – CNSTR HOOD,MED,STRAWBERRY 24 R Matrx Disposable DynoMite Nasal Hood Strawberry Medium - Matrx Breathing Circuits – 91515192 – MATRX SCAV,LG HOOD(SHUTOFF VAL / Matrx Scavenger - Large Assemblies Only Matrx Nasal Hoods – 91316485 – CNSTR HOOD,SM,VANILLA 24 CT R / Matrx Disposable DynoMite Nasal Hood Vanilla Small -Dyn Porter Breathing Circuits - 5155-2 – PORTER/BRN PEDO RG ASSY W/VB / Porter Pediatric Breathing Circuit w/ In-Line Vacuu Porter Nasal Hoods – 5053PD12C – DISP LINER,PEDO,BAG,CITRUS / Porter Pediatric Disposable Inner Mask Liners – Citrus (1 Matrx Nasal Hoods – 91316489 – CNSTR HOOD,LGE,BUBBLEGUM 24 R / Matrx Disposable DynoMite Nasal Hood Bubble Gum Large - Porter Nasal Hoods – 5054A – HOOD ASSY, ADULT/ Porter Adult Double Mask Hood Kit w/ 3 Inner Mask Liners Matrx Nasal Hoods – 91515095 – REPL MEDIUM NASAL HOOD / Matrx Reusable Nasal Hood, Medium Matrx Nasal Hoods – 91316463 – NASAL HOOD,SM,ORANGE,24CT R / Matrx Disposable DynoMite Nasal Hood Orange Small -DynoMit Porter Nasal Hoods – 5053PD12 – DISPOSABLE LINER, PEDO, BAG / Porter Pediatric Disposable Inner Mask Liners (12 Pack) Matrx Nasal Hoods – 91316493 – CNSTR HOOD,LGE,PLAIN 24 CT R / Matrx Disposable DynoMite Nasal Hood Plain Large -DynoM Matrx Nasal Hoods – 91515142 – SCAVENGER ADAPTER / Universal Conversion Package: Matrx Disposable DynoMite Nasal Hood, Matrx Nasal Hoods – 91316508 – NASAL HOOD,MED,ASSORTED 12 CT / Matrx Disposable DynoMite Nasal Hood Assorted Scents Med Matrx Nasal Hoods – 91316500 – NASAL HOOD,SM,PLAIN, 12 CT / Matrx Disposable DynoMite Nasal Hood Plain Small -DynoMite Matrx Nasal Hoods – 91316462 – NASAL HOOD,SM.STRAWBERRY,24CT / Matrx Disposable DynoMite Nasal Hood Strawberry Small -D Matrx Breathing Circuits – 82503 – SM MATRX SCAV 2/SCV, 3L BAG / Matrx Scavenger - W/3-Liter Breathing Bag and Scavenge Matrx Nasal Hoods – 91316461 – NASAL HOOD,SM,BUBBLEGUM,24CT R / Matrx Disposable DynoMite Nasal Hood Bubble Gum Small - Matrx Nasal Hoods – 91316465 – NASAL HOOD,SM,PLAIN,24CT R / Matrx Disposable DynoMite Nasal Hood Plain Small -DynoM Porter Nasal Hoods – 5054C – HOOD ASSY,ADULT,ONE LINER / Porter Adult Double Mask w/ 1 Inner Mask Liner Porter Nasal Hoods – 5053PD144 – DISPOSABLE LINER, PEDO, BOX / Porter Pediatric Disposable Inner Mask Liners (144 Pack) Matrx Nasal Hoods – 91316512 – NASAL HOOD,LGE,ORANGE, 12 CT / Matrx Disposable DynoMite Nasal Hood Orange Large -DynoMi Matrx Nasal Hoods – 91316519 – CNSTR HOOD,MED,BUBBLEGUM 24 R / Matrx Disposable DynoMite Nasal Hood Bubble Gum Medium Matrx Nasal Hoods – 91316510 – NASAL HOOD,LGE,BUBBLEGUM 12 CT / Matrx Disposable DynoMite Nasal Hood Bubble Gum Large - Matrx Nasal Hoods – 91316503 – NASAL HOOD,MED,BUBBLEGUM 12 CT / Matrx Disposable DynoMite Nasal Hood Bubble Gum Medium Matrx Nasal Hoods – 91316507 – NASAL HOOD,MED,PLAIN, 12 CT / Matrx Disposable DynoMite Nasal Hood Plain Medium -DynoMit Porter Nasal Hoods – 5053PD144C – DISP LINER,PEDO,BOX,CITRUS / Porter Pediatric Disposable Inner Mask Liners – Citrus (1 Matrx Nasal Hoods – 91316487 – CNSTR HOOD,SM,ASSORTED 24 CT R / Matrx Disposable DynoMite Nasal Hood Assorted Scents Sma Matrx Nasal Hoods – 91316492 – CNSTR HOOD,LGE,VANILLA 24 CT R / Matrx Disposable DynoMite Nasal Hood Vanilla Large -Dyn Matrx Nasal Hoods – 91316464 – NASAL HOOD,SM,VANILLA,24CT R / Matrx Disposable DynoMite Nasal Hood Vanilla Small -Dyn Matrx Nasal Hoods – 91316483 – CNSTR HOOD,SM,STRAWBERRY 24 R Matrx Disposable DynoMite Nasal Hood Strawberry Small - D Matrx Nasal Hoods – 91316475 – NASAL HOOD,LGE,BUBBLEGUM 24 R / Matrx Disposable DynoMite Nasal Hood Bubble Gum Large - Matrx Breathing Circuits – 82504 – LG MATRX SCAVENGER, 3L BAG / Matrx Scavenger Large - W/3-Liter Breathing Bag Matrx Nasal Hoods – 91316513 – NASAL HOOD,LGE,VANILLA 12 CT / Matrx Disposable DynoMite Nasal Hood Vanilla Large -DynoM Positive Pressure / Demand Valve Demand Valve Resuscitator Bag Tee – 30157400 – BAG TEE ASSY-DIGITAL MDM / Bag Tee for DMDM Flowmeter Breathing Bag - 4100-2NL – BAG,2 LITER,NON-LATEX / 2-Liter Breathing Bag Breathing Bag - 4100-3NL – BAG,3 LITER,NON-LATEX / 3-Liter Breathing Bag Bag Tee – P2407A – ORAL SURGERY BAG TEE/THREADED / Porter Oral Surgery Threaded Bag Tee Bag Tee – P1407E – BAG TEE FOR MXR & STD FLMR, CE / Bag Tee for MXR and Standard Flowmeter Bag Tee – P1407B – RETROFIT BAG T FOR MXR & STD / Bag Tee for MXR Flowmeter and MDM Flowmeter with Retrofit Adapter Bag Tee – A-1679 – REMOTE BAGTEE MNTNG BLOCK ASSY/ Bag Tee Mount Bag Tee – P1407QD – BAG TEE FOR MXR & FLMR, QD / Porter Quick Connect Bag Tee Bag Tee – 5335 – POST MT CLEAN AIR/BAG TEE ASSY / Remote Bag Tee Post Mount Bag Tee – 91525135 – KIT-BAG TEE/SCAV SWIVEL ASSY / Remote Bag Tee Bag Tee – P1407A – BAG TEE FOR MXR & STD FLMR / Porter Bag Tee Vacuum Controller – 5400SCAVPLUS – SCAV PLUS SCAVENGER Scavenger Plus Silhouette Circuits – SIL2-MED-24 – SILHOUETTE 2 CIRCUIT,MED-24 PK / Medium Silhouette 2 – 24 Pack Silhouette Circuits – SIL-START-PK – STARTER KIT,SILHOUTTE / Starter Package: 3 Silhouette Circuits of each size, Cann Silhouette Circuits – SIL2-ADPT-PKG – SILHOUETTE 2,ACCESSORY Package / Adapter Package: Cannula Adaptor, Clip with Strap Silhouette Circuits – SIL-CONN-KIT – CONNECTOR KIT,SILHOUETTE / Silhouette Connection Kit Silhouette Circuits – SIL-SIZER-4 – SILHOUETTE SIZERS,4 PACK / Silhouette Sizer Masks - Color Coded (1 of Each Size) Silhouette Circuits – SIL2-MED-144 – SILHOUETTE 2 CIRCUIT,MED,144 PK / Silhouette 2 Circuit, Medium, 144 Pack Silhouette Circuits – SIL-SM-12 – SILHOUETTE CIRCUIT,SMALL,12PAC / Small Silhouette – 12 Pack Silhouette Circuits – SIL2-PEDO-24 – SILHOUETTE 2 CIRCUIT,PEDO,24 PK / Pediatric Silhouette 2 – 24 Pack Silhouette Circuits – SIL2-MED-12 – SILHOUETTE 2 CIRCUIT,MEDIUM,12PA / Medium Silhouette 2 – 12 Pack Silhouette Circuits – SIL2-SM-24 – SILHOUETTE 2 CIRCUIT,SM,24 PK / Small Silhouette 2 – 24 Pack Silhouette Circuits – SIL-MED-144 – SILHOUETTE CIRCUIT,MED,144 PK / Silhouette Circuit, Medium, 144 Pack Silhouette Circuits – SIL-SM-24 – SILHOUETTE CIRCUIT,SM,24 PK / Small Silhouette – 24 Pack Silhouette Circuits – SIL-PEDO-12 – SILHOUETTE CIRCUIT,PEDIATRIC,1 / Pediatric Silhouette – 12 Pack Vacuum Controllers – 91515085 – FL MT MDM/CENT.MXR SCAV KIT / Matrx Scavenger Control Valves -With Ohio Quick-Connect A Gas Hoses – B-5581-001 – PARATUBE,3/8-1/4X78" EASY TEAR / Gas Supply Hose and Vacuum Tubing Silhouette Circuits – SIL2-LG-24 – SILHOUETTE 2 CIRCUIT,LG,24 PK / Large Silhouette 2 – 24 Pack Matrx Breathing Circuits – 91515197 – MATRX SCAV,SHUTOFF VALVE(WO/HO / Matrx Scavenger Without Hood Silhouette Circuits – C-1734-SM – BREATHING CIR,SILHOUETTE,SMALL / Silhouette Circuit, Small Silhouette Circuits – C-1781-SM – SIL II SMALL CIRCUIT / Silhouette 2 Circuit, Small Vacuum Controllers – 91515086 – SCAV KIT-CAB.MT CENT.MXR/MDM/R / Matrx Scavenger Control Valves -For Cabinet Mounting Silhouette Circuits – SIL2-SM-12 – SILHOUETTE 2 CIRCUIT,SMALL,12PAC / Small Silhouette 2 – 12 Pack Silhouette Circuits – SIL2-PEDO-144 – SILHOUETTE 2 CIRCUIT,PEDO,144 PK / Silhouette 2 Circuit, Pediatric, 144 Pack Silhouette Circuits – SIL-MED-24 – SILHOUETTE CIRCUIT,MED-24 PK / Medium Silhouette – 24 Pack Silhouette Circuits – SIL-ADPT-KIT – SILHOUETTE,ACCESSORY KIT / Adapter Package: Cannula Adaptor, Clip with Strap, Bag Silhouette Circuits – SIL2-PEDO-12 – SILHOUETTE 2 CIRCUIT,PEDIATRIC,1 / Pediatric Silhouette 2 – 12 Pack Silhouette Circuits – SIL-MED-12 – SILHOUETTE CIRCUIT,MEDIUM,12PA / Medium Silhouette – 12 Pack Medical Breathing Circuits – PC-1625-006 – PORTER,MED BREATH CIRCUIT,6FT / Disposable Breathing Circuit Vacuum Controllers – 91525109 – BLOCK,SCAV-DIGITAL MDM(STAND M / Matrx Scavenger Control Valves -For Digital MDM Porter Breathing Circuits – 5155-4 – PORTER/BRN PEDO RG ASSY ONLY / Porter Pediatric Breathing Circuit – No Vacuum Cont Silhouette Circuits – C-1734-LG – BREATHING CIR,SILHOUETTE,LARGE / Silhouette Circuit, Large Silhouette Circuits – C-1734-PD – BREATHING CIR,SILHOUETTE,PEDTR / Silhouette Circuit, Pediatric Silhouette Circuits – C-1734-MD – BREATHING CIR,SILHOUETTE,MEDIU / Silhouette Circuit, Medium Silhouette Circuits – SIL2-SM-144 – SILHOUETTE 2 CIRCUIT,SM,144 PK / Silhouette 2 Circuit, Small, 144 Pack Medical Breathing Circuits – DMC-12-10 – PORTER, MED BR CIR,10FT,20PCK / Medical Breathing Circuit, 20 Pack Silhouette Circuits – SIL-PEDO-144 – SILHOUETTE CIRCUIT,PEDO,144 PK / Silhouette Circuit, Pediatric, 144 Pack Silhouette Circuits – C-1781-PD – SIL II PEDIATRIC CIRCUIT / Silhouette 2 Circuit, Pediatric Medical Breathing Circuits – DMC-5301-RFK – NITRONOX HD RETROFIT KIT Disposable Breathing Circuit Retro Fit Package Vacuum Controllers – 91515083 – SCAV KIT-MDM/RA / Matrx Scavenger Control Valve for MDM Flowmeter Silhouette Circuits – C-1781-MD – SIL II MEDIUM CIRCUIT / Silhouette 2 Circuit, Medium Silhouette Circuits – SIL2-VAR-4x3 – VARIETY PACK,SILHOUETTE 2 / Silhouette 2 Variety Pack Silhouette Circuits – SIL-LG-24 – SILHOUETTE CIRCUIT,LG,24 PK / Large Silhouette – 24 Pack Silhouette Circuits – SIL2-LG-144 – SILHOUETTE 2 CIRCUIT,LG,144 PK / Silhouette 2 Circuit, Large 144 Pack Matrx Breathing Circuits – 91515196 – MATRX SCAV(WO/HOOD)WO/SHUTOFF / Matrx Scavenger without Shutoff Valve Silhouette Circuits – SIL-LG-12 – SILHOUETTE CIRCUIT,LARGE,12PAC / Large Silhouette – 12 Pack Silhouette Circuits – C-1781-LG – SIL II LARGE CIRCUIT / Silhouette Circuit, Large Silhouette Circuits – SIL-SM-144 – SILHOUETTE CIRCUIT,SM,144 PK / Silhouette Circuit, Small, 144 Pack Silhouette Circuits – SIL2-RETRO-PKG – CONNECTOR PACKAGE SILHOUETTE 2 / Connector Package: Sizer Masks, Vacuum Block Adj Silhouette Circuits – SIL-VAR-4x3 – VARIETY PACK,SILHOUETTE / Silhouette Variety Pack Medical Breathing Circuits – DMC-12 – PORTER,MED BR CIR,6FT,12PCK / Porter Medical Breathing Circuit, Pack of 12 Silhouette Circuits – SIL-PEDO-24 – SILHOUETTE CIRCUIT,PEDO,24 PK / Pediatric Silhouette – 24 Pack Silhouette Circuits – SIL2-LG-12 – SILHOUETTE 2 CIRCUIT,LARGE,12PAC / Large Silhouette 2 – 12 Pack Silhouette Circuits – SIL-LG-144 – SILHOUETTE CIRCUIT,LG,144 PK / Silhouette Circuit, Large 144 Pack Medical Breathing Circuits – DMC-12-6 – PORTER, MED BR CIR,6FT,20PCK / Medical Breathing Circuit, 20 Pack AVS – AVS-5000B – AUTO VAC SWITCH SYS,BRKT MNT / Automatic Vacuum Switch, Bracket Mount Porter Breathing Circuits – 5155-4AV – PORTER/BRN PEDO W/AVS / Porter Pediatric Breathing Circuit w/ AVS AVS – AVS-5000 – AUTO VACUUM SWITCH SYSTEM / Automatic Vacuum Switch AVS – AVS-5000C – AUTO VAC SWITCH SYS,CHAIR MNT / Automatic Vacuum Switch, Ball Mount AVS – AVS-5000S – AUTO VAC SWITCH SYS,SWIVEL MNT / Automatic Vacuum Switch, Swivel Mount AVS – AVS-5000QD – AUTO VAC.SW.SYS-QUICK DISCONN / Automatic Vacuum Switch, Quick Disconnect Porter Breathing Circuits – 5155-3AV – PORTER/BRN ADULT W/AVS / Porter Adult Breathing Circuit w/ AVS Matrx MDM – 94500150SPAIN – MDM SPAIN MODEL / MDM Assembly, Spain Matrx MDM – 94500323 – INTL MDM ASSY-AUSTRALIA(30% MI / MDM Flowmeter, Australia, 30% Matrx MDM – 94500011 – FLOWMETER ASSY,MDM / MDM Flowmeter, Std Matrx MDM – 91500167 – FLOWMETER ASSY,MDM-CAN. / MDM Flowmeter, Canada Matrx MDM – 94500150 – MDM ASSY-INTL STD ISO / MDM Flowmeter, Std ISO Matrx MDM – 94500457 – FLOWMETER ASSY,RA-CAN / MDM Flowmeter Matrx MDM – 91500401 – INTL MDM ASSY-SWEDISH(40% MIN / MDM Flowmeter, Swedish, 40% Min Matrx MDM – 94500033 – FLOWMETER ASS'Y,RA / MDM Flowmeter Matrx DMDM – 40151602SPAIN – INTL DMDM (STAND)-SPAIN / Digital MDM Assembly, Spain Matrx MDM – 91500333 – INTL MDM ASSY-FRANCE(50%MIN O2 / MDM Flowmeter, France, 50% Min O2 Matrx DMDM+Bag Tee – 91525182 – INTL DMDM (STAND)-ISRAEL / 40151602 Digital MDM, 30% Israel Matrx DMDM – 40151601 – DMDM BASIC ASSY,30 PCT / Digital MDM Matrx DMDM – 40151615 – INTL DMDM BASIC ASSY,AUSTRALIA / Digital MDM, 30% Australia / N.Z. Matrx DMDM+Bag Tee – 91525187 – INTL DMDM,CABINET MOUNT / 40151604 Digital MDM, 30%, Germany, Elbow Fittings Matrx DMDM+Bag Tee – 91525265 – INTL DMDM (STAND)-MIDDLE EAST / 40151602 Digital MDM, 30% Middle East Matrx DMDM – 40151619 – INTL DMDM BASIC ASSY, 30 / Digital MDM, 30%, International Matrx DMDM+Bag Tee – 91525184 – INTL DMDM,STANDARD-AUSTRALIA / 40151615 Digital MDM, 30% Australia / N.Z. Matrx DMDM – 40151603 – DMDM BASIC ASSY,30 PCT,L FIT,1 / Digital MDM, 30% Matrx DMDM – 40151616 – INTL DMDM BASIC ASSY,50% DUTCH / Digital MDM, 50%, Dutch Matrx DMDM+Bag Tee – 91525176 – INTL DMDM (STAND)-STD ISO / 40151602 Digital MDM, 30% Std ISO Matrx DMDM – 40151602 – DMDM BASIC ASSY,30 PCT,ST FT,2 / Digital MDM, 30%, Germany, Straight Fittings Matrx DMDM – 40151617 – INTL DMDM BASIC ASSY,30 CANADA / Digital MDM, 30%, Canada Matrx DMDM+Bag Tee – 91525179 – INTL DMDM (STAND)-SPAIN / 40151602 Digital MDM, 30%, Spain Matrx DMDM+Bag Tee – 91525115 KOR – DIGITAL MDM ASSY-120V, KOREA / Digital MDM (DMDM) Flowmeter + Bag Tee, Korea Matrx DMDM+Bag Tee – 91525180 – INTL DMDM 40% STAND-SWEDEN / 40151614 Digital MDM, 40% Sweden Matrx DMDM+Bag Tee – 91525178 – DIGITAL MDM 30% GERMANY / 40151602 Digital MDM, 30%, Germany, Straight Fittings Matrx DMDM+Bag Tee – 91525115 – DIGITAL MDM ASSY-120V, KOREA / Digital MDM (DMDM) Flowmeter + Bag Tee, 120V Matrx DMDM – 40152601 – DMDM REMOTE ASSY,30 PCT / Digital MDM, 30% O2, Remote Matrx DMDM – 40151614 – INTL DMDM BASIC ASSY, SWEDEN / Digital MDM, 40% Sweden Matrx DMDM – 40151618 – INTL DMDM BASIC ASSY,30% ITALY / Digital MDM, 30% Italy Matrx DMDM+Bag Tee – 91525185 – INTL DMDM (STAND)-DUTCH / 40151616 Digital MDM, 50%, Dutch Matrx DMDM+Bag Tee – 91525262 – INTL DMDM 30%(STAND)-ITALY / 40151618 Digital MDM, 30% Italy Matrx DMDM+Bag Tee – 91525186 – INTL DMDM (STAND)-CANADA / 40151617 Digital MDM, 30%, Canada Matrx DMDM – 40151601 KOR – DMDM BASIC ASSY,30%,KOREA / Digital MDM (DMDM) Flowmeter, Korea Matrx DMDM – 40151604 – DMDM BASIC ASSY,30 PCT,L FIT,2 / Digital MDM, 30%, Germany, Elbow Fittings Medical Face Mask – 61988000 – MOUTHPIECE (NON CE) / Disposable Mouthpiece Demand System – NOX-5000E – NITRONOX FIELD MODEL / Nitronox Emergency Unit NOX-PLUS-050 - Nitronox Plus 0-50 Model NOX-PLUS-070 - Nitronox Plus 0-70 Model NOX-PLUS-5050 - Nitronox Plus 50-50 Model Demand System – NOX-PLUS-5050 – NITRONOX PLUS 50/50 MODEL / Nitronox Plus, 50% O2, 50% N2O Demand System – NOX-5000H – NITRONOX INHALATION ANALGESIA / Nitronox Unit Demand System – NOX-PLUS-070 – NITRONOX PLUS 0-70 MODEL / Nitronox Plus, 70% N2O Demand System – NOX-PLUS-050 – NITRONOX PLUS 0-50 MODEL / Nitronox Plus, 50% N2O Demand System – NOX-5000HD – NITRONOX,HOSPITAL W/DEM VALVE / Nitronox HD Unit Mounting Options – 2100-2 – 2 CYL.CART (DUAL REGULATOR) / Two Cylinder Cart with Dual Regulators and Hoses Mounting Options – 2100 – 2 CYL.CART (LESS REGULATOR) / Two Cylinder Cart Mounting Options – 2100-N – 2 CYL.CART (N2O REGULATOR) / Two Cylinder Cart with Nitrous Oxide Regulator Sentry Sedate – Sentry-B – SENTRY SEDATE-BASIC / Sentry Sedate Porter MXR-1 – 3066W – MXR-1,FLUSH MT,50%,WHT / MXR-1, Flush Mount Flowmeter, 50% N2O white knob and tube Mounting Options – 2045-3ISO – MBL E-STND ISO W/ WHT HOSE FEM / E-Stand, Tall with Gas Supply Hoses Porter MXR-1 – C3065W15 – MXR-1,FLUSH MT,UNIVFTG/B CAN15 / MXR-1, Flush Mount Flowmeter, Universal,Bottom, ISO, 15 degr Mounting Options – 2045-SHORT3 – UND CNTR E-STND ASY, 5-STR BSE / E Stand, Compact Mounting Options – 2040 – COMPACT MOBILE STAND / Mobile Stand, Compact Porter MXR – 3000-OS – 3000-OS ORAL SURGERY MXR FMTR / MXR Flowmeter, Oral Surgery Porter MXR – C3000 – MXR,FLOWMETER ASSEMBLY / MXR, White Markings for O2, 70% Max N2O Mounting Options – 2042 – TALL MOBILE STAND / Tall Mobile Stand, Tall Porter MXR – C3000A – MXR,FLOWMETER ASSEMBLY,AUS / MXR Flowmeter, Australian Fittings Sentry Sedate – C-Sentry-B – SENTRY SEDATE BASIC,CANADA Sentry Sedate, Canada Porter MXR – 3000 – MXR FLOWMTR W/BAG TEE / MXR Flowmeter Mounting Options – 2044 – ORAL SURGERY MOBILE STAND / Mobile Stand, Extra Tall Porter MXR-1 – 3065W – MXR-1,FLUSH MT,UNIV FTG(R),WHT / MXR-1,Flush Mount Flowmeter, white knob and tube Mounting Options – 2045-3 – MOBILE E-STND ASSY, 5-STAR BSE / E Stand, Tall Porter MXR-1 – C3065W – MXR-1,FLUSH MTMUNIVER CAN / MXR-1, Flush Mount Flowmeter Universal Porter MXR – C3050 – MXR,FLOWMETER ASSY 50% N2O MAX / MXR, White Markings for O2, 70% Max N2O Porter Standard – 1100 – STD FLOWMETER W/BAG TEE / Porter Standard Flow Meter Porter MXR – DTL-164W – MXR,FLOWMETER ASSEMBLY / MXR, Swedish Connectors, White Body Mounting Options – 2045RAShort3 RA – MED UND CNTR E-STAND, 5-STR E-Stand, Short with Gas Supply Hoses Mounting Options – 2045-3RA – RA MED 27" E-STND ASSY, 5-STAR / E-Stand, Extra Tall Porter MXR-1 – 3065W15 – MXR-1,FLUSH MT,UNIVFTG/R,C15 / MXR-1,Flush Mount Flowmeter Universal,Rear, 15 degree angle Steam Sterilizer, Porter Reliant Mounting Options – 2100-NC – MED MOBILE CART / Two Cylinder Cart with Nitrous Oxide Regulator and Hose Mounting Options – 2045-SHORT – UNDER COUNTERE MOBILE E STAND E-Stand, Short Mounting Options – 2100-ISO-2 – CART,2 CYL, DUAL REG, ISO / 2-Cylinder Mobile Cart with Regulator, O2, Regulator, N2O, Mounting Options – 100-7038-050 – NOX HD-NS ACCESSORIES / NOX HD-NS 2 CYLINDER CART Mounting Options – 2100-ISO-N – CART, 2 CYL,(N2O REG),ISO / 2-Cylinder Mobile Cart with Regulator, N2O, and Gas Supply Mounting Options – 2045-2 – MOBILE E STAND ASSY,SWIVL YOKE / Mobile E-Stand Assembly, Swivel Yoke Mounting Options – 2045-SHORT3-ISO – CE UND CNTR E-STND ASY, 5-ST / E-Stand, International, Compact Mounting Options – 2045-3CA – MBLE E-STND CANADA W/ WHT HSE / E-Stand, White Hose Porter Parts - A-3919-000 - FLOWMETER,8 LPM O2,W/CONN Porter Parts - A-3919-001 - FLOWMETER, 8 LPM O2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BSZ Gas-Machine, Anesthesia Anesthesiology Class 2 868.5160 2008-10-07
BXH Gauge, Gas Pressure, Cylinder/Pipeline Anesthesiology Class 1 868.2610 2018-11-01
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2011-08-15
CBN Apparatus, Gas-Scavenging Anesthesiology Class 2 868.5430 2012-06-27
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2008-11-20
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2011-08-15
BTC Bag, Reservoir Anesthesiology Class 1 868.5320 2011-10-21
CBN Apparatus, Gas-Scavenging Anesthesiology Class 2 868.5430 2023-03-09
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2011-08-15
CBN Apparatus, Gas-Scavenging Anesthesiology Class 2 868.5430 2008-10-07
BSZ Gas-Machine, Anesthesia Anesthesiology Class 2 868.5160 2008-11-20
BSZ Gas-Machine, Anesthesia Anesthesiology Class 2 868.5160 2008-11-20
BYP Mouthpiece, Breathing Anesthesiology Class 1 868.5620 2018-11-01
BZR Mixer, Breathing Gases, Anesthesia Inhalation Anesthesiology Class 2 868.5330 2012-06-27
BZR Mixer, Breathing Gases, Anesthesia Inhalation Anesthesiology Class 2 868.5330 2021-11-01
BZR Mixer, Breathing Gases, Anesthesia Inhalation Anesthesiology Class 2 868.5330 2012-06-27
CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated Anesthesiology Class 1 868.2340 2008-10-07
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2011-03-03
FOX Stand, Infusion General Hospital Class 1 880.6990 2018-11-01
CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated Anesthesiology Class 1 868.2340 2001-08-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PRECISION FLUIDICS DIVISION PARKER HANNIFIN CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K252746 Drägerwerk AG Co. Kgaa Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) 2026-05-21
K021223 Sauter AG BELIMED STEAM STERILIZER, MODEL TOP 5000 2002-06-26
K050263 M.O. Com S.R.L. MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU 2006-11-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2011 GE Healthcare, LLC 2
GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0008-2014 Draeger Medical, Inc. 2
Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
Z-0009-2011 GE Healthcare, LLC 2
GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0009-2014 GE Healthcare, LLC 2
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Z-0010-2011 GE Healthcare, LLC 2
GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

Similar Registrations

Registration Number Establishment Name Location
9611500 Draegerwerk AG & Co. KGaA LUEBECK Schleswig-Holstein, DE
2112667 Datex-Ohmeda, Inc. MADISON, WI, US
3003589956 Flextronics Manufacturing (Singapore) Pte Ltd SINGAPORE South East, SG
3005803793 THORNHILL RESEARCH INC. TORONTO Ontario, CA
3000126629 Philips Electronics Ltd Mississauga Ontario, CA
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2518157. Last updated year: 2026. Please use registration number 2518157 when referencing this establishment in official correspondence.
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