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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 - B00928600

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

  • B00928603 ()
  • B00928600 ()

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

  • Donor-organ preservation/transport system gas refillable cylinder

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

OCS Heart System - B00925751

SvO2/HCT Probe
TRANSMEDICS, INC.
1427
In Commercial Distribution

  • B00925751 ()
  • B00925753 ()

  • Length: 9 Inch
  • Width: 5.13 Inch
  • Height: 2.3 Inch
1427

  • Extracorporeal blood parameter probe

OCS Heart System - B00925741

Coronary Flow Probe
TRANSMEDICS, INC.
1425
In Commercial Distribution

  • B00925741 ()
  • B00925743 ()

  • Length: 9 Inch
  • Width: 5.13 Inch
  • Height: 2.3 Inch
1425

  • Extracorporeal fluid flow probe

OCS Heart System - B00925721

Aortic Flow Probe
TRANSMEDICS, INC.
1424
In Commercial Distribution

  • B00925721 ()
  • B00925723 ()

  • Length: 9 Inch
  • Width: 5.13 Inch
  • Height: 2.3 Inch
1424

  • Extracorporeal fluid flow probe

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

OCS Heart System - B00924420

OCS Heart Gas Cylinder, Refill
TRANSMEDICS, INC.
1406
In Commercial Distribution

  • B00924420 ()
  • B00924423 ()

  • Length: 18 Inch
  • Width: 4 Inch
  • Height: 4 Inch
1406

  • Donor-organ preservation/transport system gas refillable cylinder

OCS Heart System - B00918043

OCS Blood Collection Set
TRANSMEDICS, INC.
1400
In Commercial Distribution

  • B00918043 ()
  • B00918185 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
1400

  • Exsanguination set

OCS Heart System - B00913600

OCS Heart Gas Cylinder
TRANSMEDICS, INC.
1406
In Commercial Distribution

  • B00913600 ()
  • B00913603 ()

  • Length: 18 Inch
  • Width: 4 Inch
  • Height: 4 Inch
1406

  • Donor-organ preservation/transport system gas refillable cylinder

OCS Heart System - B00913390

OCS Wireless Monitor, Heart
TRANSMEDICS, INC.
1410
In Commercial Distribution

  • B00913390 ()
  • B00926311 ()

  • Length: 9.5 Inch
  • Width: 8.5 Inch
  • Height: 3.5 Inch
1410

  • Donor-organ preservation/transport system control unit
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