Geratherm Medical Warming Systems

Basic Information

• Brand Name: Geratherm Medical Warming Systems
• Primary DI: 00614801001502
• Version / Model: Super Mini-Rescue II Unique Resc+ R-150
• Catalog Number: 80613
• Company Name: R.G. ENTERPRISES (U.S.A.), INC.
• Labeler DUNS: 928998905
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 23130b88-0f58-44cb-b3f8-401caaa8964f

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWJ	System, Thermal Regulating	Cardiovascular	870.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614801001502	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K093694	000

Device Sizes

Type	Value	Unit	Text
Length	19	Inch
Height	19	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -22 – 158 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity