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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 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
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 1
FLEXICARE MEDICAL LIMITED
NF-158-1U
In Commercial Distribution

  • 05055931119692 ()


  • 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
1.8m (70") with Anatomical Mask Size 1
FLEXICARE MEDICAL LIMITED
NF-157U
In Commercial Distribution

  • 05055931119678 ()


  • Ventilator breathing circuit, single-use
1.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 1
FLEXICARE MEDICAL LIMITED
NF-157-1U
In Commercial Distribution

  • 05055931119661 ()


  • Ventilator breathing circuit, single-use
1.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 0
FLEXICARE MEDICAL LIMITED
NF-157-0U
In Commercial Distribution

  • 05055931119654 ()


  • Ventilator breathing circuit, single-use
No Description
FLEXICARE MEDICAL LIMITED
NF-156U
In Commercial Distribution

  • 05055931119647 ()


  • Ventilator breathing circuit, single-use
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