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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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Molded Products, Inc. - B144MPC7450

Collection Assist Device that collects a clean sample from the female hansen port of a hemodialysis machine.
MOLDED PRODUCTS, INC.
MPC-745
In Commercial Distribution

  • B144MPC7451 ()
  • B144MPC7450 ()
  • B144MPC7452 ()
  • B144MPC7453 ()
MPC-745

  • Haemodialysis treatment kit

metra Liver Perfusion Circuit Pack - 05060462240043

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

OrganOx metra - 05060462240029

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

OCS Liver System - B00950770

OCS Liver Bile Salts Set
TRANSMEDICS, INC.
3440
In Commercial Distribution

  • B00949381 ()
  • B00950770 ()

  • Length: 4 Inch
  • Width: 4 Inch
  • Height: 4 Inch
3440

  • Donor-organ/tissue/cell preservation solution additive

OCS Liver System - B00948883

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 System - B00944843

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 System - B00944833

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

OCS Liver System - B00944823

OCS Liver Perfusion Initiation Set
TRANSMEDICS, INC.
3400
In Commercial Distribution

  • B00944895 ()
  • B00944823 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
3400

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

OCS Liver System - B00944705

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 Liver System - B00950421

Bile Cannula, 12FR
TRANSMEDICS, INC.
3450
In Commercial Distribution

  • B00950443 ()
  • B00950421 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
3450

  • Donor-organ preservation/transport perfusion set connection kit
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