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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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Kelvi Ankle Pro Smart Wrap
HYPOTHERMIA DEVICES, INC.
KLV20004
In Commercial Distribution

  • 00850001185059 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Knee Pro Smart Wrap
HYPOTHERMIA DEVICES, INC.
KLV20003
In Commercial Distribution

  • 00850001185042 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Back Pro Smart Wrap
HYPOTHERMIA DEVICES, INC.
KLV20002
In Commercial Distribution

  • 00850001185035 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Shoulder Pro Smart Wrap
HYPOTHERMIA DEVICES, INC.
KLV20001
In Commercial Distribution

  • 00850001185028 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Pro Umbilical
HYPOTHERMIA DEVICES, INC.
KLV40001
In Commercial Distribution

  • 00850001185011 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Pro Console
HYPOTHERMIA DEVICES, INC.
KLV10001
In Commercial Distribution

  • 00850001185004 ()


  • Circulating-fluid localized thermal therapy system
No Description
EMIT CORPORATION
FA100004
In Commercial Distribution

  • 00850003277042 ()
  • 00850003277073 ()
  • 00850003277066 ()
  • 00850003277059 ()
  • 00850003277097 ()
  • 00850003277080 ()


  • Conduction blood/fluid warmer
No Description
EMIT CORPORATION
FA100001
In Commercial Distribution

  • 00850003277035 ()
  • 00850003277004 ()
  • 00850003277011 ()
  • 00850003277028 ()
  • 00850003277110 ()
  • 00850003277103 ()


  • Conduction blood/fluid warmer
Adult Smoothbore BiPAP Breathing System 1.8m
FLEXICARE MEDICAL LIMITED
038-35-300/2U
In Commercial Distribution

  • 05055931131861 ()


  • Ventilator breathing circuit, single-use
1.8m (70") Oxygen Line 2.1m (82") and Round Masks Size 0
FLEXICARE MEDICAL LIMITED
NF-158-0U
In Commercial Distribution

  • 05055931119685 ()


  • Ventilator breathing circuit, single-use
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