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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3-wire lead set and plug, snap, (IEC)
Philips Medical Systems Hsg
3-Wire Lead Set and Plug Snap IEC
Not in Commercial Distribution

  • 00884838002777 ()
M3528A

  • Electrocardiographic lead set, reusable
3-Lead ECG Cable, FR3, AAMI
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
3-Lead ECG Cable, FR3, AAMI
Not in Commercial Distribution

  • 00884838050006 ()
989803150041

  • Electrocardiographic lead set, reusable
FR2 ECG Assessment Module
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
M3874A
Not in Commercial Distribution

  • 00884838049963 ()


  • Electrocardiographic lead set, reusable
FR2 ECG Assessment Module, AAMI
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
M3873A
Not in Commercial Distribution

  • 00884838049956 ()


  • Electrocardiographic lead set, reusable
CABLE 2035W 4 LEAD CRYO ROHS CEA MDR
MEDTRONIC, INC.
2035W
In Commercial Distribution

  • 00763000306502 ()


  • Electrocardiographic lead set, reusable
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 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 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 Console
TRANSMEDICS, INC.
3000
In Commercial Distribution

  • B00950491 ()
  • B00950480 ()

  • Length: 17 Inch
  • Height: 29 Inch
  • Width: 28 Inch
3000

  • Liver donor-organ preservation/transport system
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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