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 Class Implantable

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OCS Data Card
TRANSMEDICS, INC.
1404
In Commercial Distribution

  • B00953975 ()
  • B00953973 ()

  • Length: 1 Inch
  • Width: 1.25 Inch
  • Height: 0.08 Inch
1404

  • Data storage card
OCS Heart Console
TRANSMEDICS, INC.
1000
In Commercial Distribution

  • B00949290 ()
  • B00949711 ()

  • Length: 17 Inch
  • Width: 28 Inch
  • Height: 29 Inch
1000

  • Heart donor-organ preservation/transport system
OCS Heart Solution Line Set
TRANSMEDICS, INC.
1457
In Commercial Distribution

  • B00948913 ()
  • B00948925 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
1457

  • Donor-organ preservation/transport perfusion initiation/termination set
OCS Heart Perfusion Set
TRANSMEDICS, INC.
1200
In Commercial Distribution

  • B00948225 ()
  • B00948227 ()

  • Length: 31 Inch
  • Width: 18 Inch
  • Height: 18 Inch
1200

  • Heart donor-organ preservation/transport perfusion set
Cable Tie Tool, Small Diameter
TRANSMEDICS, INC.
1461
In Commercial Distribution

  • B00943661 ()
  • B00943675 ()

  • Length: 12 Inch
  • Width: 9 Inch
  • Height: 2 Inch
1461

  • Donor-organ preservation/transport perfusion set vessel tie tool
OCS Cardioplegic Arrest Set
TRANSMEDICS, INC.
1421
In Commercial Distribution

  • B00936463 ()
  • B00936655 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
1421

  • Donor-organ preservation/transport perfusion initiation/termination set
OCS Heart Instrumentation Tool Set
TRANSMEDICS, INC.
1401
In Commercial Distribution

  • B00936363 ()
  • B00936645 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
1401

  • Donor-organ preservation/transport perfusion set connection kit
OCS Heart Solution Set
TRANSMEDICS, INC.
1300
In Commercial Distribution

  • B00926340 ()
  • B00926341 ()

  • Length: 20 Inch
  • Width: 15 Inch
  • Height: 3 Inch
1300

  • Donor-organ/tissue/cell preservation solution
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
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
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