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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Double Nasal Hood Single Use, Adult, Scent Blueberry Dance 12 Hoods individually wrapped in a box. To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Baldus Sedation GmbH & Co. KG
NHA12BD
In Commercial Distribution

  • 04260635790431 ()


  • Anaesthesia face mask, single-use
Thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached. Operates using battery or medical grade power supply.
R.G. ENTERPRISES (U.S.A.), INC.
Super Mini-Rescue II Unique Resc+ R-150
In Commercial Distribution

  • 00614801001502 ()

  • Length: 19 Inch
  • Height: 19 Inch
80613

  • Rescue blanket, reusable
Thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached. Operates using battery or medical grade power supply.
R.G. ENTERPRISES (U.S.A.), INC.
Mini-Rescue II UniqueResc R130
In Commercial Distribution

  • 00614801001304 ()

  • Length: 33 Inch
  • Height: 19 Inch
80612

  • Rescue blanket, reusable
Battery for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
R.G. ENTERPRISES (U.S.A.), INC.
Brentronics Battery Assembly
In Commercial Distribution

  • 00614801000055 ()
82015

  • Portable/mobile rechargeable battery pack
Battery for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
R.G. ENTERPRISES (U.S.A.), INC.
Ultralife Battery Assembly
In Commercial Distribution

  • 00614801000048 ()
82039

  • Portable/mobile rechargeable battery pack
Auxiliary Vehicle Cable for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
R.G. ENTERPRISES (U.S.A.), INC.
Aux Vehicle Cable
In Commercial Distribution

  • 00614801000031 ()
82019

  • Electrical mains power extension cable
Battery Adapter Cable for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
R.G. ENTERPRISES (U.S.A.), INC.
Battery Adapter Cable
In Commercial Distribution

  • 00614801000024 ()
82024

  • Electrical mains power extension cable
Power Supply Unit for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
R.G. ENTERPRISES (U.S.A.), INC.
Power Supply Unit
In Commercial Distribution

  • 00614801000017 ()
82009

  • Basic power supply, reusable
Charger assembly for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
R.G. ENTERPRISES (U.S.A.), INC.
Charger Assembly Lithium Ion Battery
In Commercial Distribution

  • 00614801000000 ()
82025

  • Noninvasive device battery charger
The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
Raya Pharmaceuticals LLC
1
In Commercial Distribution

  • 00382098017062 ()


  • Pulse oximeter probe, reusable
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