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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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No Description
FLEXICARE MEDICAL LIMITED
FL2000-05U
In Commercial Distribution

  • 05055788767985 ()


  • Heated respiratory humidifier
No Description
FLEXICARE MEDICAL LIMITED
038-01-140U
In Commercial Distribution

  • 05055788750505 ()


  • Ventilator breathing circuit, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-01-150U
In Commercial Distribution

  • 05055788750352 ()


  • Ventilator breathing circuit, single-use
Kelvi Hip Pro Smart Wrap, Right
HYPOTHERMIA DEVICES, INC.
KLV20009
In Commercial Distribution

  • 00850001185110 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Hip Pro Smart Wrap, Left
HYPOTHERMIA DEVICES, INC.
KLV20008
In Commercial Distribution

  • 00850001185103 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Hand Station
HYPOTHERMIA DEVICES, INC.
KLV20005
In Commercial Distribution

  • 00850001185073 ()


  • Circulating-fluid localized thermal therapy system
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
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
1.8m (70") with Anatomical Masks Sizes 0 + 1
FLEXICARE MEDICAL LIMITED
NF-156-NTU
In Commercial Distribution

  • 05055931119630 ()


  • Ventilator breathing circuit, single-use
1.8m (70") Oxygen Line 2.1m (82") Round Masks Sizes 0 + 1
FLEXICARE MEDICAL LIMITED
NF-155U
In Commercial Distribution

  • 05055931119623 ()


  • Ventilator breathing circuit, single-use
1.8m (70") with Round Masks Sizes 0 + 1
FLEXICARE MEDICAL LIMITED
NF-155-NTU
In Commercial Distribution

  • 05055931119616 ()


  • Ventilator breathing circuit, single-use
No Description
FLEXICARE MEDICAL LIMITED
NF-150U
In Commercial Distribution

  • 05055931119609 ()


  • Ventilator breathing circuit, single-use
1.8m (70") Oxygen Line 2.1m (82") Catheter Access Adapter
FLEXICARE MEDICAL LIMITED
NF-056U
In Commercial Distribution

  • 05055931119579 ()


  • Ventilator breathing circuit, single-use
Infant Resuscitator T-Piece Circuit 1.9m (75") with Tethered Cap and Adjustable PEEP
FLEXICARE MEDICAL LIMITED
NF-151U
In Commercial Distribution

  • 05055931117636 ()


  • Ventilator breathing circuit, single-use
Respiratory Humidifier Single Use Temperature Probe (Sterile)
FLEXICARE MEDICAL LIMITED
FL9000-04STRU
In Commercial Distribution

  • 05055931112983 ()


  • Heated respiratory humidifier
Respiratory Humidifier Single Use Temperature Probe
FLEXICARE MEDICAL LIMITED
FL9000-04U
In Commercial Distribution

  • 05055931111009 ()


  • Heated respiratory humidifier
Infant Resus Kit T-Piece Circuit 1.9m (75") with Filter, O2 Line 2.1m (82") Round Mask Size 1
FLEXICARE MEDICAL LIMITED
NF-188-1U
In Commercial Distribution

  • 05055931106715 ()


  • Ventilator breathing circuit, single-use
Infant Resus Kit T-Piece Circuit 1.9m (75") with Filter, O2 Line 2.1m (82") Round Mask Size 0
FLEXICARE MEDICAL LIMITED
NF-188-0U
In Commercial Distribution

  • 05055931106692 ()


  • Ventilator breathing circuit, single-use
Infant Resus Kit T-Piece Circuit 1.9m (75") with Filter, Anatomical Mask Size 1
FLEXICARE MEDICAL LIMITED
NF-187U
In Commercial Distribution

  • 05055931106678 ()


  • Ventilator breathing circuit, single-use
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