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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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EMBOL-X Intra-Aortic Filter with Duraflo Coating - 00690103166378

EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXXLD
In Commercial Distribution

  • 00690103166378 ()

  • ID 35-40 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXXLD

  • Embolic protection filtering guidewire

Intersept® - 00673978707358

FILTER 1338 PEDIATRIC ARTERIAL 8PK 8L
MEDTRONIC, INC.
1338
Not in Commercial Distribution

  • 20673978707352 ()
  • 00673978707358 ()


  • Cardiopulmonary bypass system filter, arterial blood line

WalkMed® - 00859695006039

Pump Tubing Set with 0.2 micron filter for WalkMed Infusion Pump, 170 cm
WALKMED TECHNOLOGIES, LLC
204383
In Commercial Distribution

  • 00859695006039 ()
  • 10859695006036 ()

  • Pore Size: 0.2 Micrometer
  • Length: 170 Centimeter
FPS-560

  • Electric infusion pump administration set, single-use

WalkMed® - 00859695006022

Pump Tubing Set with check valve and filter for WalkMed Infusion Pump, 102 cm
WALKMED TECHNOLOGIES, LLC
203728
In Commercial Distribution

  • 10859695006029 ()
  • 00859695006022 ()

  • Length: 102 Centimeter
  • Pore Size: 0.2 Micrometer
EFV-101B

  • Electric infusion pump administration set, single-use

Atlas SSLR Buttress Assembly - 00851677007140

Atlas SSLR Buttress Assembly
STANDARD BARIATRICS, INC
IPN928199
In Commercial Distribution

  • 00851677007140 ()
  • 20851677007144 ()
SSLR23

  • Staple line-reinforcement strip

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

QUART - 04037691253862

The QUART arterial filter (HBF 140) with SOFTLINE coating, sterile, is a screen filter with integrated bypass and pre-postdeairing mechanic. It is used for removing gaseous embolisms and aggregates from blood components of the arterial bloodline during extracorporeal circulation. Therefore utilization of the arterial filter reduces the patient’s risk of injury from a micro embolism caused by gases or solids.
Maquet Cardiopulmonary AG
BO-HBF 140, SOFTLINE, Sterile
Not in Commercial Distribution

  • 04037691117911 ()
  • 04037691253862 ()

  • Area/Surface Area: 570 Square centimeter
  • maximum blood flow [l/min] 7 0
  • connection size inlet 3/8 Inch
  • connection size outlet 3/8 Inch
  • priming volume 180 Milliliter
  • Pore Size: 40 Micrometer
70103.2033

  • Blood transfusion filter

QUART - 04037691173412

QUART Arterial Filter with BIOLINE Coating, Sterile. The QUART arterial filter (HBF 140) is a screen filter with integrated bypass and pre-postdeairing mechanic. It is used for removing gaseous embolisms and aggregates from blood components of the arterial bloodline during extracorporeal circulation. Therefore utilization of the arterial filter reduces the patient’s risk of injury from a micro embolism caused by gases or solids.
Maquet Cardiopulmonary AG
BEQ-HBF 140 Arterial Filter, Sterile
Not in Commercial Distribution

  • 04037691173412 ()
  • 04037691173405 ()

  • Area/Surface Area: 570 Square centimeter
  • maximum blood flow [l/min] 7 0
  • connection size inlet 3/8 Inch
  • connection size outlet 3/8 Inch
  • priming volume 180 Milliliter
  • Pore Size: 40 Micrometer
70101.2811

  • Blood transfusion filter

QUART - 04037691078977

Quart Arterial Filter, no coating, HBF 140#Arterieller Filter Quart
Maquet Cardiopulmonary AG
QUART Arterial Filter
Not in Commercial Distribution

  • 04037691190402 ()
  • 04037691078977 ()
  • 04037691004907 ()

  • Pore Size: 40 Micrometer
  • priming volume 180 Milliliter
  • connection size outlet 3/8 Inch
  • connection size inlet 3/8 Inch
  • maximum blood flow [l/min] 7 0
  • Area/Surface Area: 570 Square centimeter
70100.4263

  • Blood transfusion filter

ECHLEON - 10705036023296

ECHELON 60MM REINFORCEMENT
ETHICON ENDO-SURGERY, LLC
ECH60R
In Commercial Distribution

  • 20705036023293 ()
  • 10705036023296 ()
  • 30705036023290 ()
ECH60R

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

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

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

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

Biodesign - 00827002250079

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

  • 00827002250079 ()
C-SLRA-TRI60

  • Staple line-reinforcement strip

Biodesign - 00827002250062

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G25006
Not in Commercial Distribution

  • 00827002250062 ()
C-SLRA-TRI45

  • Staple line-reinforcement strip

Biodesign - 00827002236622

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G23662
Not in Commercial Distribution

  • 00827002236622 ()
C-SLRA-TN45

  • Staple line-reinforcement strip

Biodesign - 00827002232013

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G23201
Not in Commercial Distribution

  • 00827002232013 ()
C-SLRA-SC60

  • Staple line-reinforcement strip

Biodesign - 00827002248274

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G24827
Not in Commercial Distribution

  • 00827002248274 ()
C-SLRA-TN60

  • Staple line-reinforcement strip

TRILLIUM® Affinity® - 00721902363597

FILTER 351T TRILL AFFINITY
MEDTRONIC, INC.
351T
Not in Commercial Distribution

  • 20721902363591 ()
  • 00721902363597 ()

  • Pore Size: 38.0 Micrometer


  • Cardiopulmonary bypass system filter, arterial blood line

CAPIOX®ARTERIAL FILTER - 04987350763358

No Description
TERUMO CORPORATION
CX*AF125X
In Commercial Distribution

  • 54987350763353 ()
  • 04987350763358 ()


  • Cardiopulmonary bypass system filter, arterial blood line

CAPIOX® VENOUS RESERVOIR - 04987350706690

No Description
TERUMO CORPORATION
CX*VRA1001T2
In Commercial Distribution

  • 34987350706691 ()
  • 04987350706690 ()


  • Cardiotomy reservoir

CAPIOX® VENOUS RESERVOIR - 04987350706591

No Description
TERUMO CORPORATION
CX*VRA0701T2
In Commercial Distribution

  • 34987350706592 ()
  • 04987350706591 ()


  • Cardiotomy reservoir

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

Medex - 10351688516916

No Description
ICU MEDICAL, INC.
MXG300146
In Commercial Distribution

  • 50351688516914 ()
  • 10351688516916 ()


  • Invasive-pressure external transducer, single-use

Medex - 10351688510624

No Description
ICU MEDICAL, INC.
M20858R1
In Commercial Distribution

  • 50351688510622 ()
  • 10351688510624 ()


  • Pressure transducer dome, single-use
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