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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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EXCHANGER 61399400964 12CA HT BIOTHERM
MEDTRONIC, INC.
61399400964
Not in Commercial Distribution

  • 00613994009647 ()


  • Cardiopulmonary bypass system heat exchanger, reusable
EXCHANGER 61399400870 12CA EMOTRMII HT
MEDTRONIC, INC.
61399400870
Not in Commercial Distribution

  • 00613994008701 ()


  • Cardiopulmonary bypass system heat exchanger, reusable
Optiflow Oxygen Kit
FISHER & PAYKEL HEALTHCARE LIMITED
AA451J
In Commercial Distribution

  • 09420012477927 ()
  • 09420012477910 ()
AA451J

  • Humidified oxygen administration set
No Description
Omm Imports Inc.
GZ100
In Commercial Distribution

  • 00850001456456 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red/ir device for the treatment of wrinkles.
Omm Imports Inc.
J700B-B
In Commercial Distribution

  • 00850001456128 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red/IR led device for the treatment of wrinkles.
Omm Imports Inc.
J700B-S
In Commercial Distribution

  • 00850001456111 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red/IR device for the treatment of wrinkles.
Omm Imports Inc.
PX100
In Commercial Distribution

  • 00850001456036 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red and infrared phototherapy device for the treatment of wrinkles.
Omm Imports Inc.
P900B
In Commercial Distribution

  • 00850001456012 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red and infrared phototherapy device for the treatment of wrinkles.
Omm Imports Inc.
P850B
In Commercial Distribution

  • 00850001456005 ()


  • Blue/red/infrared phototherapy lamp
ShuntCheck Test Pack consisting of a ShuntCheck Thermosensor, an Instant Cold Pack and a skin marker in a clamshell container
NEURODX DEVELOPMENT LLC
TP-1
In Commercial Distribution

  • 00865435000335 ()
  • 10865435000318 ()
TP-1

  • Heater/cooler system tester kit
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