AccessGUDID - DEVICE: Geratherm Medical Warming Systems (00614801001304)

GUDID

Device Identifier (DI) Information

Brand Name: Geratherm Medical Warming Systems
Version or Model: Mini-Rescue II UniqueResc R130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80612
Company Name: R.G. ENTERPRISES (U.S.A.), INC.

Primary DI Number: 00614801001304
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 928998905 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
10416	Rescue blanket, reusable	A large sheet of material specially designed to keep a person warm and to prevent the further loss of body heat in an emergency rescue situation. It is typically used by emergency medical services (EMS) and typically includes a heat-reflecting metal surface [e.g., aluminium (Al)] to help retain body heat. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWJ	System, Thermal Regulating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093694	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -22 and 158 Degrees Fahrenheit
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 33 Inch
Height: 19 Inch

Device Record Status

Public Device Record Key: 3d224447-90a9-4eb0-bf5d-2b4b1ba02887
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 01, 2016