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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 - 00827002248274

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

  • 00827002248274 ()
C-SLRA-TN60

  • 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

ECHLEON - 10705036023296

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

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

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

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 - 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

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 - 10351688508881

No Description
ICU MEDICAL, INC.
MX20787
In Commercial Distribution

  • 50351688508889 ()
  • 10351688508881 ()


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

Medex - 10351688508690

No Description
ICU MEDICAL, INC.
MX20877
In Commercial Distribution

  • 50351688508698 ()
  • 10351688508690 ()


  • Basic intravenous administration set, noninvasive

Medex - 10351688508560

No Description
ICU MEDICAL, INC.
MX20896R1
In Commercial Distribution

  • 50351688508568 ()
  • 10351688508560 ()


  • Invasive-pressure external transducer, single-use

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

Medex - 10351688500540

No Description
ICU MEDICAL, INC.
SM5020
In Commercial Distribution

  • 50351688500548 ()
  • 10351688500540 ()


  • Electric infusion pump administration set, single-use

Medex - 10351688500533

No Description
ICU MEDICAL, INC.
SM5021
In Commercial Distribution

  • 50351688500531 ()
  • 10351688500533 ()


  • Electric infusion pump administration set, single-use

Medex - 10351688500472

No Description
ICU MEDICAL, INC.
SM872
In Commercial Distribution

  • 50351688500470 ()
  • 10351688500472 ()


  • Electric infusion pump administration set, single-use

Medex - 10351688500458

No Description
ICU MEDICAL, INC.
SM872M
In Commercial Distribution

  • 50351688500456 ()
  • 10351688500458 ()


  • Electric infusion pump administration set, single-use

Medex - 10351688500441

No Description
ICU MEDICAL, INC.
SM873
In Commercial Distribution

  • 50351688500449 ()
  • 10351688500441 ()


  • Electric infusion pump administration set, single-use

Medex - 10351688500410

No Description
ICU MEDICAL, INC.
SM90976
In Commercial Distribution

  • 50351688500418 ()
  • 10351688500410 ()


  • Electric infusion pump administration set, single-use

Medex - 10351688516916

No Description
ICU MEDICAL, INC.
MXG300146
In Commercial Distribution

  • 50351688516914 ()
  • 10351688516916 ()


  • Invasive-pressure external transducer, single-use

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

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

Medline Industries, Inc. - 10195327664459

CENTRAL LINE
MEDLINE INDUSTRIES, INC.
DYNDC3413
In Commercial Distribution

  • 40195327664450 ()
  • 10195327664459 ()
DYNDC3413

  • General surgical procedure kit, non-medicated, single-use

Jaeger - 14250892907311

Sample line
Jaeger Medical GmbH
V-707722
In Commercial Distribution

  • 14250892907311 ()
V-707722

  • Pulmonary function analysis system, adult

Jaeger - 14250892907298

Sample line
Jaeger Medical GmbH
707226
In Commercial Distribution

  • 14250892907298 ()
707226

  • Cardiopulmonary stress exercise monitoring system
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