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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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CAPIOX® VENOUS RESERVOIR - 04987350706492

No Description
TERUMO CORPORATION
CX*VRA0401T2
In Commercial Distribution

  • 34987350706493 ()
  • 04987350706492 ()


  • Cardiotomy reservoir

CAPIOX® VENOUS RESERVOIR - 04987350706393

No Description
TERUMO CORPORATION
CX*VRA0101T2
In Commercial Distribution

  • 34987350706394 ()
  • 04987350706393 ()


  • Cardiotomy reservoir

CAPIOX®ARTERIAL FILTER - 04987350705631

No Description
TERUMO CORPORATION
CX*AF02
In Commercial Distribution

  • 54987350705636 ()
  • 04987350705631 ()


  • Cardiopulmonary bypass system filter, arterial blood line

NEOVEIL - 04973077713783

As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon. Two forms of NEOVEIL are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL staple line reinforcement ranges from 0.1 mm to 0.85 mm. Mesh weave characteristics and pore size are not applicable since NEOVEIL is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m2).
GUNZE LIMITED
NV-ET-M60L-3
In Commercial Distribution

  • 04973077713783 ()

  • Length: 60 Millimeter
  • Width: 17 Millimeter
NV-ET-M60L-3

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

NEOVEIL - 04973077713776

NEOVEIL Staple Line Reinforcement is composed of a biodegradable synthetic polymer, polyglycolic acid(PGA) and is offered as a nonwoven surgical mesh configured into sleeves. The device is applied to the surgical site via a mechanical stapler with two jaws, where one piece of the sleeve is slid over each jaw of the stapler. This is accomplished by attaching a similar-sized piece of nonabsorbable elastic knit to the PGA felt that is held together by means of PGA tacking threads. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The PGA material is dyed with D&C Green No.6.
GUNZE LIMITED
NV-ET-M60E-3
In Commercial Distribution

  • 04973077713776 ()

  • Length: 60 Millimeter
  • Width: 17 Millimeter
NV-ET-M60E-3

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

MedStream - 00842472100372

FILTER-PEDIATRIC .22 MCRN
MEDICAL SPECIALTIES DISTRIBUTORS, LLC
MS428
In Commercial Distribution

  • 10842472100379 ()
  • 00842472100372 ()
MS428

  • Intravenous administration tubing extension set

Affinity® - 00613994309334

FILTER S4014 AFFINITYPEDIATRIC ART ST
MEDTRONIC, INC.
S4014
In Commercial Distribution

  • 20613994309338 ()
  • 00613994309334 ()


  • Cardiopulmonary bypass system filter, arterial blood line

Affinity Pixie™ - 00613994617323

ARTERIAL FILTER BB4014PEDS BB STERILE
MEDTRONIC, INC.
BB4014
In Commercial Distribution

  • 20613994617327 ()
  • 00613994617323 ()


  • Cardiopulmonary bypass system filter, arterial blood line

Affinity® - 00681490008532

FILETR CB353 BIOAC 20M AFFINITY
MEDTRONIC, INC.
CB353
Not in Commercial Distribution

  • 20681490008536 ()
  • 00681490008532 ()

  • Pore Size: 20.0 Micrometer


  • Cardiopulmonary bypass system filter, arterial blood line

Affinity® - 00681490008525

FILTER CB351 ART 38M 6/B 6PK
MEDTRONIC, INC.
CB351
Not in Commercial Distribution

  • 20681490008529 ()
  • 00681490008525 ()

  • Pore Size: 38.0 Micrometer


  • Cardiopulmonary bypass system filter, arterial blood line

Affinity® - 00681490008020

FILTER 61399409503 AFFINITY ART 354 6PK
MEDTRONIC, INC.
61399409503
In Commercial Distribution

  • 20681490008024 ()
  • 00681490008020 ()

  • Pore Size: 20.0 Micrometer


  • Cardiopulmonary bypass system filter, arterial blood line

EXTENSION SET - 00085412653297

Micro-Volume Extension Set with 0.2 m Filter
BAXTER HEALTHCARE CORPORATION
2N3382
In Commercial Distribution

  • 50085412653292 ()
  • 00085412653297 ()

  • Total Volume: 0.75 Milliliter
  • Pressure: 45 Pound per Square Inch
  • Length: 1500000000000000 Femtometer
2N3382

  • Intravenous administration tubing extension set

FLUID SYSTEMS ACCESSORIES - 00085412639444

Air Eliminating 1.2 micrometer Solution Filter
BAXTER HEALTHCARE CORPORATION
2N3368
In Commercial Distribution

  • 50085412639449 ()
  • 00085412639444 ()

  • Pressure: 29 Pound per Square Inch
  • Total Volume: 0.8 Milliliter
  • Pore Size: 0.000001200000 Meter
2N3368

  • Intravenous administration tubing extension set

EXTENSION SET - 00085412639338

Micro-Volume Extension Set with 0.2 Micrometer Filter
BAXTER HEALTHCARE CORPORATION
2N3357
In Commercial Distribution

  • 50085412639333 ()
  • 00085412639338 ()

  • Pressure: 45 Pound per Square Inch
  • Length: 2000000000000000 Femtometer
  • Total Volume: 0.88 Milliliter
2N3357

  • Intravenous administration tubing extension set

MICRO - 08033178114608

No Description
SORIN GROUP ITALIA SRL
40 µm Infant Arterial Filter
In Commercial Distribution

  • 38033178114609 ()
  • 08033178114608 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178114578

No Description
SORIN GROUP ITALIA SRL
40 µm Adult Arterial Filter
In Commercial Distribution

  • 38033178114579 ()
  • 08033178114578 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178114561

No Description
SORIN GROUP ITALIA SRL
40 µm Small Adult Arterial Filter
In Commercial Distribution

  • 38033178114562 ()
  • 08033178114561 ()


  • Cardiopulmonary bypass system filter, arterial blood line

KIDS - 08033178109314

No Description
SORIN GROUP ITALIA SRL
D131 INFANT ART. FILTER PH + PURGE LINE
In Commercial Distribution

  • 38033178109315 ()
  • 08033178109314 ()


  • Cardiopulmonary bypass system filter, arterial blood line

KIDS - 08033178109154

No Description
SORIN GROUP ITALIA SRL
D130 NEONATAL ART.FILTER PH+PURGE LINE
In Commercial Distribution

  • 38033178109155 ()
  • 08033178109154 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178100892

No Description
SORIN GROUP ITALIA SRL
D736 40µ NEW BORN ART.FILTER+PURGE LINE
In Commercial Distribution

  • 38033178100893 ()
  • 08033178100892 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178100885

No Description
SORIN GROUP ITALIA SRL
D735 27µ NEW BORN ART.FILTER+PURGE LINE
In Commercial Distribution

  • 38033178100886 ()
  • 08033178100885 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178100847

No Description
SORIN GROUP ITALIA SRL
D734 40µ AD ART. FILTER + PURGE LINE
In Commercial Distribution

  • 38033178100848 ()
  • 08033178100847 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178100830

No Description
SORIN GROUP ITALIA SRL
D732 27µ AD ART. FILTER + PURGE LINE
In Commercial Distribution

  • 38033178100831 ()
  • 08033178100830 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178100823

No Description
SORIN GROUP ITALIA SRL
D733 40µ PED ART. FILTER + PURGE LINE
In Commercial Distribution

  • 38033178100824 ()
  • 08033178100823 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178100816

No Description
SORIN GROUP ITALIA SRL
D731 27µ PED ART. FILTER + PURGE LINE
In Commercial Distribution

  • 38033178100817 ()
  • 08033178100816 ()


  • Cardiopulmonary bypass system filter, arterial blood line

Biodesign - 00827002506565

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50656
Not in Commercial Distribution

  • 00827002506565 ()
C-SLRA-GIA30

  • Staple line-reinforcement strip

INTERLINK - 00085412065298

Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filter and Pressure Pump, Injection Site, Male Luer Lock Adapter with Retractable Collar
BAXTER INTERNATIONAL INC.
4C6839
Not in Commercial Distribution

  • 50085412065293 ()
  • 00085412065298 ()
4C6839

  • Blood transfusion set, non-exchange

INTERLINK - 00085412031194

Y-Type Blood/Solution Set, 40 and 150 Micron Dual Screen Filter, Injection Site, Male Luer Lock Adapter with Retractable Collar
BAXTER INTERNATIONAL INC.
4C6838
Not in Commercial Distribution

  • 50085412031199 ()
  • 00085412031194 ()
4C6838

  • Blood transfusion set, non-exchange

EXTENSION SET - 00085412660387

Micro-Volume Catheter Extension Set with 0.2 micrometer Filter
BAXTER HEALTHCARE CORPORATION
2N3386
In Commercial Distribution

  • 50085412660382 ()
  • 00085412660387 ()

  • Length: 250000000000000 Femtometer
  • Pore Size: 0.00000020 Meter
  • Pressure: 45 Pound per Square Inch
  • Total Volume: 0.44 Milliliter
2N3386

  • Intravenous administration tubing extension set

Biodesign - 00827002250079

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G25007
Not in Commercial Distribution

  • 00827002250079 ()
C-SLRA-TRI60

  • Staple line-reinforcement strip
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