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 Liver Solution Infusion Set
TRANSMEDICS, INC.
3457
In Commercial Distribution

  • B00948895 ()
  • B00948883 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
3457

  • Donor-organ preservation/transport perfusion initiation/termination set
OCS Liver Gas Cylinder, Refill
TRANSMEDICS, INC.
3406
In Commercial Distribution

  • B00946653 ()
  • B00946650 ()

  • Length: 18 Inch
  • Width: 4 Inch
  • Height: 4 Inch
3406

  • Donor-organ preservation/transport system gas refillable cylinder
OCS Liver Gas Cylinder
TRANSMEDICS, INC.
3406
In Commercial Distribution

  • B00946643 ()
  • B00946640 ()

  • Length: 18 Inch
  • Width: 4 Inch
  • Height: 4 Inch
3406

  • Donor-organ preservation/transport system gas refillable cylinder
OCS Liver Perfusion Termination Set
TRANSMEDICS, INC.
3421
In Commercial Distribution

  • B00944915 ()
  • B00944843 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
3421

  • Donor-organ preservation/transport perfusion initiation/termination set
OCS Liver Instrumentation Tool Set
TRANSMEDICS, INC.
3401
In Commercial Distribution

  • B00944905 ()
  • B00944833 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
3401

  • Donor-organ preservation/transport perfusion set connection kit
The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macro steatosis less than or equal to 15 percent, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0146_US
In Commercial Distribution

  • 05060462240043 ()


  • Liver donor-organ preservation/transport system
The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macrosteatosis less than or equal to 15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0146
In Commercial Distribution

  • 05060462240029 ()


  • Liver donor-organ preservation/transport system
The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macro steatosis less than or equal to 15 percent, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0003
In Commercial Distribution

  • 05060462240005 ()


  • Liver donor-organ preservation/transport system
No Description
Sterilance Medical (Suzhou) Inc.
01-0126
In Commercial Distribution

  • 36945630123079 ()
  • 16945630123075 ()
  • 06945630123078 ()


  • Blood lancet, single-use
No Description
EXACT SCIENCES CORPORATION
1.1
In Commercial Distribution

  • 00858637005901 ()


  • Laboratory instrument/analyser application software IVD
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