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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Pall LeukoGuard BC2 Blood Cardioplegia Filter
Pall International Sàrl
BC2B
In Commercial Distribution

  • 35034480306105 ()
  • 05034480306104 ()

  • Reduce the level of leucocytes and exclude microemboli greater than 40 µm in size
  • Pore Size: 40 Micrometer
BC2B

  • Cardiopulmonary bypass system filter, blood/cardioplegia solution
Pall LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop
Global Life Sciences Solutions USA LLC
LGB
Not in Commercial Distribution

  • 35034480004056 ()
  • 05034480004055 ()

  • Pore Size: 40 Micrometer
  • Reduce the levels of circulating leucocytes and exclude microemboli greater than 40 µm in size
LGB

  • Cardiopulmonary bypass system filter, arterial blood line
Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service
Pall International Sàrl
LG6
In Commercial Distribution

  • 35034480000393 ()
  • 05034480000392 ()

  • Pore Size: 40 Micrometer
  • Reduce the levels of circulating leucocytes and exclude microemboli greater than 40 µm in size
LG6

  • Cardiopulmonary bypass system filter, arterial blood line
Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service (with Bypass Loop)
Pall International Sàrl
LG6B
In Commercial Distribution

  • 35034480000409 ()
  • 05034480000408 ()

  • Reduce the levels of circulating leucocytes and exclude microemboli greater than 40 µm in size
  • Pore Size: 40 Micrometer
LG6B

  • Cardiopulmonary bypass system filter, arterial blood line
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
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
FILTER-PEDIATRIC .22 MCRN
MEDICAL SPECIALTIES DISTRIBUTORS, LLC
MS428
In Commercial Distribution

  • 10842472100379 ()
  • 00842472100372 ()
MS428

  • Intravenous administration tubing extension set
No Description
ICU MEDICAL, INC.
MXG300146
In Commercial Distribution

  • 50351688516914 ()
  • 10351688516916 ()


  • Invasive-pressure external transducer, single-use
No Description
ICU MEDICAL, INC.
M20858R1
In Commercial Distribution

  • 50351688510622 ()
  • 10351688510624 ()


  • Pressure transducer dome, single-use
No Description
ICU MEDICAL, INC.
M20869R2
In Commercial Distribution

  • 50351688510615 ()
  • 10351688510617 ()


  • Pressure transducer dome, single-use
No Description
ICU MEDICAL, INC.
MX20462
In Commercial Distribution

  • 50351688509459 ()
  • 10351688509451 ()


  • Invasive-pressure external transducer, single-use
No Description
ICU MEDICAL, INC.
MX20787
In Commercial Distribution

  • 50351688508889 ()
  • 10351688508881 ()


  • Tube/mask breathing circuit connector, single-use, sterile
No Description
ICU MEDICAL, INC.
MX20877
In Commercial Distribution

  • 50351688508698 ()
  • 10351688508690 ()


  • Basic intravenous administration set, noninvasive
No Description
ICU MEDICAL, INC.
MX20896R1
In Commercial Distribution

  • 50351688508568 ()
  • 10351688508560 ()


  • Invasive-pressure external transducer, single-use
No Description
ICU MEDICAL, INC.
MX6029
In Commercial Distribution

  • 50351688506359 ()
  • 10351688506351 ()


  • Angiography kit
No Description
ICU MEDICAL, INC.
MX700312
In Commercial Distribution

  • 50351688505758 ()
  • 10351688505750 ()


  • Angiography kit
No Description
ICU MEDICAL, INC.
MXG300128
In Commercial Distribution

  • 50351688501224 ()
  • 10351688501226 ()


  • Invasive-pressure external transducer, single-use
No Description
ICU MEDICAL, INC.
SM5009
In Commercial Distribution

  • 50351688500593 ()
  • 10351688500595 ()


  • In-line backflow valve, single-use
No Description
ICU MEDICAL, INC.
SM5020
In Commercial Distribution

  • 50351688500548 ()
  • 10351688500540 ()


  • Electric infusion pump administration set, single-use
No Description
ICU MEDICAL, INC.
SM5021
In Commercial Distribution

  • 50351688500531 ()
  • 10351688500533 ()


  • Electric infusion pump administration set, single-use
No Description
ICU MEDICAL, INC.
SM872
In Commercial Distribution

  • 50351688500470 ()
  • 10351688500472 ()


  • Electric infusion pump administration set, single-use
No Description
ICU MEDICAL, INC.
SM872M
In Commercial Distribution

  • 50351688500456 ()
  • 10351688500458 ()


  • Electric infusion pump administration set, single-use
No Description
ICU MEDICAL, INC.
SM873
In Commercial Distribution

  • 50351688500449 ()
  • 10351688500441 ()


  • Electric infusion pump administration set, single-use
No Description
ICU MEDICAL, INC.
SM90976
In Commercial Distribution

  • 50351688500418 ()
  • 10351688500410 ()


  • Electric infusion pump administration set, single-use
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
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
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
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
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 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
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
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
G50868
Not in Commercial Distribution

  • 00827002508682 ()
C-SLRA-GIA45

  • 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
G50656
Not in Commercial Distribution

  • 00827002506565 ()
C-SLRA-GIA30

  • 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
G50867
Not in Commercial Distribution

  • 00827002508675 ()
C-SLRA-GIA60

  • 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
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
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
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
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
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
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