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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 Liver Perfusion Set
TRANSMEDICS, INC.
3200
In Commercial Distribution

  • B00944707 ()
  • B00944705 ()

  • Length: 27 Inch
  • Width: 27 Inch
  • Height: 21 Inch
3200

  • Liver donor-organ preservation/transport perfusion set
OCS Lung Solution
TRANSMEDICS, INC.
2300
In Commercial Distribution

  • B00944671 ()
  • B00944670 ()

  • Height: 2.5 Inch
  • Width: 5.5 Inch
  • Length: 14 Inch
2300

  • Donor-organ/tissue/cell preservation solution
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 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
OCS Lung Manual Inflation Set
TRANSMEDICS, INC.
2404
In Commercial Distribution

  • B00940013 ()
  • B00940001 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2404

  • Breathing circuit bag, single-use
OCS Wireless Monitor, Universal
TRANSMEDICS, INC.
2450
In Commercial Distribution

  • B00939301 ()
  • B00939270 ()

  • Height: 3.5 Inch
  • Width: 8.5 Inch
  • Length: 9.5 Inch
2450

  • Donor-organ preservation/transport system control unit
OCS Lung Monitoring Gas Regulator Kit
TRANSMEDICS, INC.
2464
In Commercial Distribution

  • B00939313 ()
  • B00939251 ()

  • Height: 3 Inch
  • Width: 12 Inch
  • Length: 10 Inch
2464

  • Donor-organ preservation/transport system gas cylinder regulator
OCS Lung Console
TRANSMEDICS, INC.
2000
In Commercial Distribution

  • B00939231 ()
  • B00939240 ()

  • Height: 29 Inch
  • Width: 28 Inch
  • Length: 17 Inch
2000

  • Lung donor-organ preservation/transport system
OCS Lung Monitoring Gas Cylinder, Refill
TRANSMEDICS, INC.
2461
In Commercial Distribution

  • B00939183 ()
  • B00939180 ()

  • Height: 4 Inch
  • Width: 4 Inch
  • Length: 18 Inch
2461

  • Donor-organ preservation/transport system gas refillable cylinder
OCS Lung Monitoring Gas Cylinder
TRANSMEDICS, INC.
2461
In Commercial Distribution

  • B00939173 ()
  • B00939170 ()

  • Height: 4 Inch
  • Width: 4 Inch
  • Length: 18 Inch
2461

  • Donor-organ preservation/transport system gas refillable cylinder
OCS Lung Instrumentation Tool Set
TRANSMEDICS, INC.
2401
In Commercial Distribution

  • B00937673 ()
  • B00939111 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2401

  • Donor-organ preservation/transport perfusion set connection kit
OCS Lung Perfusion Set
TRANSMEDICS, INC.
2200
In Commercial Distribution

  • B00938535 ()
  • B00938537 ()

  • Height: 21 Inch
  • Width: 27 Inch
  • Length: 27 Inch
2200

  • Lung donor-organ preservation/transport perfusion set
OCS Lung Perfusion Termination Set
TRANSMEDICS, INC.
2403
In Commercial Distribution

  • B00937663 ()
  • B00937641 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2403

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