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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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COMFORT FLO Humidification System
TELEFLEX INCORPORATED
IPN913728
Not in Commercial Distribution

  • 44026704659348 ()
  • 34026704659341 ()
  • 14026704659347 ()
2410

  • Ventilator breathing circuit, single-use
Rechargeable battery pack for powering the °M Warmer
Mequ A/S
MWS106
In Commercial Distribution

  • 05745000140046 ()
MWS106

  • Conduction blood/fluid warmer
Rechargeable battery pack for powering the °M Warmer
Mequ A/S
MWS105
In Commercial Distribution

  • 05745000140039 ()
MWS105

  • Conduction blood/fluid warmer
The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances. The °MEQU °M Warmer System Starter Kit consists of three components: The °M Warmer (a single-patient use, disposable IV fluid / blood warmer unit – primary DI number 05700002076816), the Power Pack+ (a multi-patient, reusable, rechargeable battery pack for powering the °M Warmer – primary DI number 05745000140046) and the Charger (a reusable charger for recharging the battery pack – primary DI number 05700002076847).
Mequ A/S
MWS006
In Commercial Distribution

  • 05745000140022 ()
MWS006

  • Conduction blood/fluid warmer
Ebb Insomnia Therapy headgear assembly without the tube sleeve for clinical demonstrations to allow the tubing to be wiped down for cleaning.
CEREVE INC
EOS-30000-054
In Commercial Distribution

  • 00864302000355 ()
10401

  • Circulating-fluid localized thermal therapy system
Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and tubing, fluid cartridge, and power supply that cools the forehead while the patient sleeps. This listing is for the replacement forehead pad with tubing.
CEREVE INC
EOS-30000-013
In Commercial Distribution

  • 00864302000348 ()


  • Circulating-fluid localized thermal therapy system
Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and tubing, fluid cartridge, and power supply that cools the forehead while the patient sleeps. This listing is for the replacement cartridge.
CEREVE INC
EOS-30000-031
In Commercial Distribution

  • 00864302000331 ()


  • Circulating-fluid localized thermal therapy system
Replenish kit including replacement fluid cartridge and headgear with tubing for the Ebb Insomnia Therapy system.
CEREVE INC
10200
In Commercial Distribution

  • 00864302000324 ()


  • Circulating-fluid localized thermal therapy system
Packages an Ebb Insomnia Therapy Starter kit with a replenish kit, 2 replacement cartridges and a travel bag.
CEREVE INC
VA Kit
In Commercial Distribution

  • 00864302000317 ()


  • Circulating-fluid localized thermal therapy system
Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and tubing, fluid cartridge, and power supply that cools the forehead while the patient sleeps.
CEREVE INC
EOS-30000-007
In Commercial Distribution

  • 00864302000300 ()


  • Circulating-fluid localized thermal therapy system
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