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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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OCS Lung System - B00928590

OCS Lung Preservation Gas Cylinder
TRANSMEDICS, INC.
2460
In Commercial Distribution

  • B00928593 ()
  • B00928590 ()

  • Height: 4 Inch
  • Width: 4 Inch
  • Length: 18 Inch
2460

  • Donor-organ preservation/transport system gas refillable cylinder

Organ Care System - B00925681

OCS Regulator Yoke Gasket
TRANSMEDICS, INC.
1423
In Commercial Distribution

  • B00954003 ()
  • B00925681 ()

  • Height: 0.08 Inch
  • Width: 0.6 Inch
  • Length: 0.6 Inch
1423

  • Gas/fluid regulator gasket

Organ Care System - B00913320

OCS Mobile Base
TRANSMEDICS, INC.
1411
In Commercial Distribution

  • B00925711 ()
  • B00913320 ()

  • Height: 10 Inch
  • Width: 28 Inch
  • Length: 21 Inch
1411

  • Utility trolley

Organ Care System - B00912500

OCS Battery
TRANSMEDICS, INC.
1408
In Commercial Distribution

  • B00912501 ()
  • B00912500 ()

  • Height: 3 Inch
  • Width: 2 Inch
  • Length: 10 Inch
1408

  • Portable/mobile rechargeable battery pack

OCS Lung System - B00943281

OCS Lung Perfusion Initiation Set
TRANSMEDICS, INC.
2402
In Commercial Distribution

  • B00943281 ()
  • B00937703 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2402

  • Donor-organ preservation/transport perfusion initiation/termination set

Organ Care System - B00925731

Pump Flow Probe
TRANSMEDICS, INC.
1426
In Commercial Distribution

  • B00925733 ()
  • B00925731 ()

  • Height: 2.3 Inch
  • Width: 5.13 Inch
  • Length: 9 Inch
1426

  • Extracorporeal fluid flow probe

NMP22 BladderChek Test - 00811877011538

NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Alere Scarborough, Inc.
D1200
In Commercial Distribution

  • 00811877011538 ()


  • Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical

Alere NMP22 BladderChek Test - 10811877010774

The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Alere Scarborough, Inc.
D1300
Not in Commercial Distribution

  • 10811877010774 ()


  • Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical

Alere NMP22 BladderChek Test - 10811877010569

The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Alere Scarborough, Inc.
D1200
Not in Commercial Distribution

  • 10811877010569 ()


  • Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical

Organ Care System - B00914051

OCS Power Cord, North America
TRANSMEDICS, INC.
1432
In Commercial Distribution

  • B00954033 ()
  • B00914051 ()

  • Height: 2 Inch
  • Width: 10 Inch
  • Length: 8 Inch
1432

  • Electrical mains power cable
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