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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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SUPPLEMENTAL VALVE LINE, ME - B066H73950

A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.
NOVOSCI CORP.
H-7395
In Commercial Distribution

  • B066H73953 ()
  • B066H73950 ()
H-7395

  • Cardiopulmonary bypass system blood tubing set

THI PURGE LINE W/O VALVE, TX. - B066491196A0

A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.
NOVOSCI CORP.
491196-A
In Commercial Distribution

  • B066491196A3 ()
  • B066491196A0 ()
491196-A

  • Cardiopulmonary bypass system blood tubing set

LINE, ARTERIAL FILTER PURGE - B0662010080000

A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.
NOVOSCI CORP.
201008-000
In Commercial Distribution

  • B0662010080000 ()
  • B0662010080007 ()
  • B0662010080006 ()
  • B0662010080005 ()
  • B0662010080003 ()
201008-000

  • Cardiopulmonary bypass system filter, arterial blood line

Biodesign - 00827002232013

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

  • 00827002232013 ()
C-SLRA-SC60

  • Staple line-reinforcement strip

Biodesign - 00827002542525

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G54252
Not in Commercial Distribution

  • 00827002542525 ()
C-SLRA-OPEN-GIA80

  • Staple line-reinforcement strip

Biodesign - 00827002542518

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G54251
Not in Commercial Distribution

  • 00827002542518 ()
C-SLRA-OPEN-GIA60

  • Staple line-reinforcement strip

Biodesign - 00827002517462

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G51746
Not in Commercial Distribution

  • 00827002517462 ()
C-SLRA-ECH45

  • Staple line-reinforcement strip

Biodesign - 00827002508682

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50868
Not in Commercial Distribution

  • 00827002508682 ()
C-SLRA-GIA45

  • Staple line-reinforcement strip

Biodesign - 00827002508668

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50866
Not in Commercial Distribution

  • 00827002508668 ()
C-SLRA-TCT-TLC55

  • Staple line-reinforcement strip

Biodesign - 00827002506565

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

  • 00827002506565 ()
C-SLRA-GIA30

  • Staple line-reinforcement strip

Biodesign - 00827002508712

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50871
Not in Commercial Distribution

  • 00827002508712 ()
C-SLRA-ECH60

  • Staple line-reinforcement strip

Biodesign - 00827002508705

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50870
Not in Commercial Distribution

  • 00827002508705 ()
C-SLRA-EZ45

  • Staple line-reinforcement strip

Biodesign - 00827002508675

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50867
Not in Commercial Distribution

  • 00827002508675 ()
C-SLRA-GIA60

  • Staple line-reinforcement strip

Biodesign - 00827002508651

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50865
Not in Commercial Distribution

  • 00827002508651 ()
C-SLRA-TCT-TLC75

  • Staple line-reinforcement strip

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

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

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

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

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

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 - 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 - 00827002248274

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

  • 00827002248274 ()
C-SLRA-TN60

  • 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

TRILLIUM® AFFINITY® - 00885074252223

FILTER 353T AFFINITY 20M TRILLIUM 6PK
MEDTRONIC, INC.
353T
Not in Commercial Distribution

  • 20885074252227 ()
  • 00885074252223 ()

  • 20 MIC Filter Pore Size


  • Cardiopulmonary bypass system filter, arterial blood line

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132644780

IntuitiveDaVinciXi60Black
W. L. Gore & Associates, Inc.
20055721
In Commercial Distribution

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

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce - 00733132644773

IntuitiveDaVinciXi60Green
W. L. Gore & Associates, Inc.
20055724
In Commercial Distribution

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

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

Pressure Monitoring Lines - 00886333201297

Pressure Monitoring Lines Blue 48" Injection Line w/Male & Female Luer Lock Connectors
ARGON MEDICAL DEVICES, INC.
040504005A
Not in Commercial Distribution

  • 20886333201291 ()
  • 00886333201297 ()

  • 48" Injection Line
040504005A

  • Cardiopulmonary bypass system pressure-monitoring tubing
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