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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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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
Rubber Dam Frame
POMEE CORPORATION
711-585
In Commercial Distribution

  • G1577115850 ()
711-585

  • Rubber dam frame
Paragonix SherpaPak Cardiac Transport System HC 32mm
Paragonix Technologies Inc
SHRP-1001-000-004
In Commercial Distribution

  • 00869582000385 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System HC 25.4mm
Paragonix Technologies Inc
SHRP-1001-000-003
In Commercial Distribution

  • 00869582000378 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System HC 18mm
Paragonix Technologies Inc
SHRP-1001-000-002
In Commercial Distribution

  • 00869582000361 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System HC 10mm
Paragonix Technologies Inc
SHRP-1001-000-001
In Commercial Distribution

  • 00869582000354 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System Canister Ships with 4 heart connectors: 00869582000354 (10mm x 1) 00869582000361 (18mm x 1) 00869582000378 (25.4mm x 1) 00869582000385 (32mm x 1)
Paragonix Technologies Inc
SHRP-1001
In Commercial Distribution

  • 00869582000347 ()
  • 00869582000309 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Heart Connector Box Contains 4 heart connectors: 00869582000354 (10mm x 1) 00869582000361 (18mm x 1) 00869582000378 (25.4mm x 1) 00869582000385 (32mm x 1)
Paragonix Technologies Inc
SHRP-1001-003
Not in Commercial Distribution

  • 00869582000330 ()


  • General-purpose donor-organ preservation/transport system
KidneyVault Cannula Multi-Pack (3, 5, 7, 9, 7x20, 10x35)
Paragonix Technologies Inc
PRGNX-8008-010
In Commercial Distribution

  • 00850005470632 ()
  • 00850005470625 ()


  • General-purpose donor-organ preservation/transport system
KidneyVault Cannula Multipack (3mm, 5mm, 7mm, 9mm, 7x20mm)
Paragonix Technologies Inc
PRGNX-8008-010
Not in Commercial Distribution

  • 00850005470588 ()
  • 00850005470571 ()


  • General-purpose donor-organ preservation/transport system
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