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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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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 - 00827002517462

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

  • 00827002517462 ()
C-SLRA-ECH45

  • 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 - 00827002508682

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

  • 00827002508682 ()
C-SLRA-GIA45

  • 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 - 00827002508668

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

  • 00827002508668 ()
C-SLRA-TCT-TLC55

  • 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

Biodesign - 00827002506565

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

  • 00827002506565 ()
C-SLRA-GIA30

  • 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

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 - 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 - 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 - 08033178114578

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

  • 38033178114579 ()
  • 08033178114578 ()


  • 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

ECHLEON - 10705036023296

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

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

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

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

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

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

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

Medex - 10351688508881

No Description
ICU MEDICAL, INC.
MX20787
In Commercial Distribution

  • 50351688508889 ()
  • 10351688508881 ()


  • Tube/mask breathing circuit connector, single-use, sterile

Medex - 10351688508560

No Description
ICU MEDICAL, INC.
MX20896R1
In Commercial Distribution

  • 50351688508568 ()
  • 10351688508560 ()


  • Invasive-pressure external transducer, single-use

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

Medex - 10351688510617

No Description
ICU MEDICAL, INC.
M20869R2
In Commercial Distribution

  • 50351688510615 ()
  • 10351688510617 ()


  • Pressure transducer dome, single-use

Medex - 10351688509451

No Description
ICU MEDICAL, INC.
MX20462
In Commercial Distribution

  • 50351688509459 ()
  • 10351688509451 ()


  • Invasive-pressure external transducer, single-use

Medex - 10351688508690

No Description
ICU MEDICAL, INC.
MX20877
In Commercial Distribution

  • 50351688508698 ()
  • 10351688508690 ()


  • Basic intravenous administration set, noninvasive

SACRED HEART AORTIC LINE, FL - B066H79150

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-7915
In Commercial Distribution

  • B066H79153 ()
  • B066H79150 ()
H-7915

  • Cardiopulmonary bypass system blood tubing set

E. MAINE MEM. ADAPTER PK. - ME - B066H75560

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-7556
In Commercial Distribution

  • B066H75563 ()
  • B066H75560 ()
H-7556

  • Cardiopulmonary bypass system blood tubing set

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

Medex - 10351688506351

No Description
ICU MEDICAL, INC.
MX6029
In Commercial Distribution

  • 50351688506359 ()
  • 10351688506351 ()


  • Angiography kit

Medex - 10351688505750

No Description
ICU MEDICAL, INC.
MX700312
In Commercial Distribution

  • 50351688505758 ()
  • 10351688505750 ()


  • Angiography kit

Medex - 10351688501226

No Description
ICU MEDICAL, INC.
MXG300128
In Commercial Distribution

  • 50351688501224 ()
  • 10351688501226 ()


  • Invasive-pressure external transducer, single-use

Medex - 10351688500595

No Description
ICU MEDICAL, INC.
SM5009
In Commercial Distribution

  • 50351688500593 ()
  • 10351688500595 ()


  • In-line backflow valve, single-use
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