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
FL2000-02U
In Commercial Distribution

  • 05055788768012 ()


  • Heated respiratory humidifier
No Description
FLEXICARE MEDICAL LIMITED
FL2000-04U
In Commercial Distribution

  • 05055788767992 ()


  • Heated respiratory humidifier
No Description
FLEXICARE MEDICAL LIMITED
2109060-001
In Commercial Distribution

  • 05055788776673 ()


  • Ventilator breathing circuit, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-33-402U
In Commercial Distribution

  • 05055788771081 ()


  • Ventilator breathing circuit, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-31-405U
In Commercial Distribution

  • 05055788771050 ()


  • Ventilator breathing circuit, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-31-404U
In Commercial Distribution

  • 05055788771036 ()


  • Ventilator breathing circuit, single-use
No Description
FLEXICARE MEDICAL LIMITED
FL9000-01U
In Commercial Distribution

  • 05055788768050 ()


  • Heated respiratory humidifier
No Description
FLEXICARE MEDICAL LIMITED
FL9000-03U
In Commercial Distribution

  • 05055788768036 ()


  • Heated respiratory humidifier
No Description
FLEXICARE MEDICAL LIMITED
FL2000-01U
In Commercial Distribution

  • 05055788768029 ()


  • Heated respiratory humidifier
No Description
FLEXICARE MEDICAL LIMITED
FL2000-03U
In Commercial Distribution

  • 05055788768005 ()


  • Heated respiratory humidifier
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
Grey trolley (new logo)
ENERGIST LIMITED
SPA Grey Trolley
In Commercial Distribution

  • 05060440520334 ()
930-023

  • Nitrogen plasma skin surface treatment system
Neogen Trolley Complete Gry
ENERGIST LIMITED
Trolley Gry
In Commercial Distribution

  • 05060440520280 ()
930-020

  • Nitrogen plasma skin surface treatment system
Neogen Trolley Complete Blk
ENERGIST LIMITED
Trolley Blk
In Commercial Distribution

  • 05060440520273 ()
930-002

  • Nitrogen plasma skin surface treatment system
NeoGen 25mm 3x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 25mm 3x Nozzle (Grey)
In Commercial Distribution

  • 15060440520263 ()
  • 05060440520266 ()
830-060

  • Nitrogen plasma skin surface treatment system
NeoGen 5mm 3x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 5mm 3x Nozzle (Grey)
In Commercial Distribution

  • 15060440520256 ()
  • 05060440520259 ()
830-059

  • Nitrogen plasma skin surface treatment system
NeoGen 25mm 3x Nozzle (Black)
ENERGIST LIMITED
NeoGen 25mm 3x Nozzle (Black)
In Commercial Distribution

  • 15060440520249 ()
  • 05060440520242 ()
830-058

  • Nitrogen plasma skin surface treatment system
NeoGen 5mm 3x Nozzle (Black)
ENERGIST LIMITED
NeoGen 5mm 3x Nozzle (Black)
In Commercial Distribution

  • 15060440520232 ()
  • 05060440520235 ()
830-057

  • Nitrogen plasma skin surface treatment system
NeoGen 25mm 1x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 25mm 1x Nozzle (Grey)
In Commercial Distribution

  • 15060440520225 ()
  • 05060440520228 ()
830-023

  • Nitrogen plasma skin surface treatment system
NeoGen 5mm 1x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 5mm 1x Nozzle (Grey)
In Commercial Distribution

  • 15060440520218 ()
  • 05060440520211 ()
830-033

  • Nitrogen plasma skin surface treatment system
NeoGen 25mm 1x Nozzle (Black)
ENERGIST LIMITED
NeoGen 25mm 1x Nozzle (Black)
In Commercial Distribution

  • 15060440520201 ()
  • 05060440520204 ()
830-024

  • Nitrogen plasma skin surface treatment system
NeoGen 5mm 1x Nozzle (Black)
ENERGIST LIMITED
NeoGen 5mm 1x Nozzle (Black)
In Commercial Distribution

  • 15060440520195 ()
  • 05060440520198 ()
830-006

  • Nitrogen plasma skin surface treatment system
Handpiece Complete (Grey)
ENERGIST LIMITED
Handpiece Gry
In Commercial Distribution

  • 05060440520129 ()
830-031

  • Nitrogen plasma skin surface treatment system
Neogen Handpiece Complete (Black)
ENERGIST LIMITED
Handpiece Blk
In Commercial Distribution

  • 05060440520105 ()
830-009

  • Nitrogen plasma skin surface treatment system
A mobile assembly of devices intended to treat a variety of skin conditions (e.g., acne scars, actinic keratosis, wrinkles, superficial skin lesions, warts) through controlled heating of the skin surface via application of nitrogen plasma. It consists of a mains electricity (AC-powered) generator/control unit and a hand-held applicator; it may include a N2 cylinder(s) and additional hardware (e.g., foot-switch). Typically radio-frequency energy is used to convert N2 into N2 plasma which exits the handpiece as a pulsed beam. This device is intended to be used by a professional in a clinical setting.
ENERGIST LIMITED
PSR
In Commercial Distribution

  • 05060440520099 ()
830-008

  • Nitrogen plasma skin surface treatment 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
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
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