Geratherm Medical Warming Systems 80613

GUDID 00614801001502

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.

Rescue blanket Rescue blanket Rescue blanket, reusable Rescue blanket, reusable Rescue blanket, reusable Rescue blanket, reusable Rescue blanket, reusable Rescue blanket, reusable Rescue blanket, reusable

• Primary Device ID: 00614801001502
• NIH Device Record Key: 23130b88-0f58-44cb-b3f8-401caaa8964f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geratherm Medical Warming Systems
• Version Model Number: Super Mini-Rescue II Unique Resc+ R-150
• Catalog Number: 80613
• Company DUNS: 928998905
• Company Name: R.G. ENTERPRISES (U.S.A.), INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 248-504-6726
• Email: MaryRN@rgmd.com
• Phone: 248-504-6726
• Email: MaryRN@rgmd.com
• Phone: 248-504-6726
• Email: MaryRN@rgmd.com
• Phone: 248-504-6726
• Email: MaryRN@rgmd.com
• Phone: 248-504-6726
• Email: MaryRN@rgmd.com
• Phone: 248-504-6726
• Email: MaryRN@rgmd.com
• Phone: 248-504-6726
• Email: MaryRN@rgmd.com
• Phone: 248-504-6726
• Email: MaryRN@rgmd.com
• Phone: 248-504-6726
• Email: MaryRN@rgmd.com

Device Dimensions

• Height: 19 Inch
• Height: 19 Inch
• Height: 19 Inch
• Height: 19 Inch
• Length: 19 Inch
• Height: 19 Inch
• Length: 19 Inch
• Height: 19 Inch
• Length: 19 Inch
• Height: 19 Inch
• Length: 19 Inch
• Height: 19 Inch
• Length: 19 Inch
• Height: 19 Inch
• Length: 19 Inch
• Height: 19 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614801001502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093694

FDA Product Code

• DWJ: System, Thermal Regulating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [Geratherm Medical Warming Systems]

• 00614801001502: Thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on
• 00614801001304: Thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on