Medical Warming Systems 82025

GUDID 00614801000000

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.

Noninvasive device battery charger

• Primary Device ID: 00614801000000
• NIH Device Record Key: 3260cdbc-5022-4d62-bffd-d75c1a5db22f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medical Warming Systems
• Version Model Number: Charger Assembly Lithium Ion Battery
• Catalog Number: 82025
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614801000000 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-11
• Device Publish Date: 2025-04-03

On-Brand Devices [Medical Warming Systems]

• 00614801000055: Battery for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or
• 00614801000048: Battery for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or
• 00614801000031: Auxiliary Vehicle Cable for thermal regulating systems to prevent/treat hypothermia in pre clini
• 00614801000024: Battery Adapter Cable for thermal regulating systems to prevent/treat hypothermia in pre clinica
• 00614801000017: Power Supply Unit for thermal regulating systems to prevent/treat hypothermia in pre clinical se
• 00614801000000: Charger assembly for thermal regulating systems to prevent/treat hypothermia in pre clinical set