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

  • 00690103166361 ()

  • ID 32-35 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXLLD

  • Embolic protection filtering guidewire
EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXMMD
In Commercial Distribution

  • 00690103166354 ()

  • ID 29-32 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXMMD

  • Embolic protection filtering guidewire
EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXSSD
In Commercial Distribution

  • 00690103166347 ()

  • ID 26-29 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXSSD

  • Embolic protection filtering guidewire
EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXXSD
In Commercial Distribution

  • 00690103166330 ()

  • ID 22-26 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXXSD

  • Embolic protection filtering guidewire
No Description
Terumo Cardiovascular Systems Corporation
CX*AF200X
In Commercial Distribution

  • 50699753450382 ()
  • 00699753450387 ()


  • Cardiopulmonary bypass system filter, arterial blood line
No Description
Terumo Cardiovascular Systems Corporation
AL6X
In Commercial Distribution

  • 50699753450016 ()
  • 00699753450011 ()


  • Cardiopulmonary bypass system filter, arterial blood line
IntuitiveDaVinciXi60Black
W. L. Gore & Associates, Inc.
20055721
In Commercial Distribution

  • 00733132644766 ()
  • 00733132644780 ()
  • 00733132644735 ()
20055721

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
IntuitiveDaVinciXi60Green
W. L. Gore & Associates, Inc.
20055724
In Commercial Distribution

  • 00733132644759 ()
  • 00733132644773 ()
  • 00733132644742 ()
20055724

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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
FILTER-PEDIATRIC .22 MCRN
MEDICAL SPECIALTIES DISTRIBUTORS, LLC
MS428
In Commercial Distribution

  • 10842472100379 ()
  • 00842472100372 ()
MS428

  • Intravenous administration tubing extension set
FILTER S4014 AFFINITYPEDIATRIC ART ST
MEDTRONIC, INC.
S4014
In Commercial Distribution

  • 20613994309338 ()
  • 00613994309334 ()


  • Cardiopulmonary bypass system filter, arterial blood line
FILTER CB4014 AFF PED ART CC ST CEM 4PK
MEDTRONIC, INC.
CB4014
Not in Commercial Distribution

  • 20613994404897 ()
  • 00613994404893 ()


  • Cardiopulmonary bypass system filter, arterial blood line
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G24827
Not in Commercial Distribution

  • 00827002248274 ()
C-SLRA-TN60

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G25007
Not in Commercial Distribution

  • 00827002250079 ()
C-SLRA-TRI60

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G25006
Not in Commercial Distribution

  • 00827002250062 ()
C-SLRA-TRI45

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G23662
Not in Commercial Distribution

  • 00827002236622 ()
C-SLRA-TN45

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G23201
Not in Commercial Distribution

  • 00827002232013 ()
C-SLRA-SC60

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G51746
Not in Commercial Distribution

  • 00827002517462 ()
C-SLRA-ECH45

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50871
Not in Commercial Distribution

  • 00827002508712 ()
C-SLRA-ECH60

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50870
Not in Commercial Distribution

  • 00827002508705 ()
C-SLRA-EZ45

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50868
Not in Commercial Distribution

  • 00827002508682 ()
C-SLRA-GIA45

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50867
Not in Commercial Distribution

  • 00827002508675 ()
C-SLRA-GIA60

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50866
Not in Commercial Distribution

  • 00827002508668 ()
C-SLRA-TCT-TLC55

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50865
Not in Commercial Distribution

  • 00827002508651 ()
C-SLRA-TCT-TLC75

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50656
Not in Commercial Distribution

  • 00827002506565 ()
C-SLRA-GIA30

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G54252
Not in Commercial Distribution

  • 00827002542525 ()
C-SLRA-OPEN-GIA80

  • Staple line-reinforcement strip
Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G54251
Not in Commercial Distribution

  • 00827002542518 ()
C-SLRA-OPEN-GIA60

  • Staple line-reinforcement strip
No Description
SORIN GROUP ITALIA SRL
40 µm Infant Arterial Filter
In Commercial Distribution

  • 38033178114609 ()
  • 08033178114608 ()


  • Cardiopulmonary bypass system filter, arterial blood line
No Description
SORIN GROUP ITALIA SRL
40 µm Small Adult Arterial Filter
In Commercial Distribution

  • 38033178114562 ()
  • 08033178114561 ()


  • Cardiopulmonary bypass system filter, arterial blood line
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
No Description
SORIN GROUP ITALIA SRL
40 µm Adult Arterial Filter
In Commercial Distribution

  • 38033178114579 ()
  • 08033178114578 ()


  • Cardiopulmonary bypass system filter, arterial blood line
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
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
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
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
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
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
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
ECHELON 60MM REINFORCEMENT
ETHICON ENDO-SURGERY, LLC
ECH60R
In Commercial Distribution

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

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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 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 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
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
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
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
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
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