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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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Paragonix SherpaPak Cardiac Transport System - 00869582000354

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 - 00869582000347

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 Cardiac Transport System - 00869582000330

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

CELSIOR Cold Storage Solution - 13700911900126

Sterile, non-pyrogenic cold flush, storage and transport solution for Hearts.
INSTITUT GEORGES LOPEZ
CELSIOR 1L US
In Commercial Distribution

  • 13700911900126 ()
  • 23700911900123 ()
533682

  • Donor-organ/tissue/cell preservation solution

Servator H - 00851983008060

Servator H Solution is intended for flushing and cold storage of abdominal organs at the time of removal from the donor in preparation fort storage, transportation, and the eventual transplantation into a recipient.
GLOBAL TRANSPLANT SOLUTIONS, INC.
GTS-SERV-HTK-5000
In Commercial Distribution

  • 00851983008060 ()


  • Kidney donor-organ preservation/transport perfusion set

OCS Lung Donor Flush Set - B00958753

OCS Lung Donor Flush Set
TRANSMEDICS, INC.
2406
In Commercial Distribution

  • B00958755 ()
  • B00958753 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2406

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

OCS Lung System - B00944670

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

XprESS Ultra - 00857326005147

ENT Dilation System 6x8mm
STRYKER CORPORATION
MSB&LLF
In Commercial Distribution

  • 00857326005147 ()
  • 10857326005144 ()
ULF-206

  • Nasal/paranasal balloon catheter
  • Eustachian catheter, single-use

XprESS Ultra - 00857326005130

ENT Dilation System 5x8mm
STRYKER CORPORATION
MSB&LLF
In Commercial Distribution

  • 00857326005130 ()
  • 10857326005137 ()
ULF-205

  • Nasal/paranasal balloon catheter
  • Eustachian catheter, single-use

XprESS Ultra - 00857326005123

ENT Dilation System 6x20mm
STRYKER CORPORATION
MSB&LLF
In Commercial Distribution

  • 00857326005123 ()
  • 10857326005120 ()
ULF-106

  • Eustachian catheter, single-use
  • Nasal/paranasal balloon catheter
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