Identity
- Trade Name
- Geratherm Medical Warming Systems FDA UDI
- Generic Name
- Rescue blanket, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Mini-Rescue II UniqueResc R130 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 80612 FDA UDI
- Primary DI / UDI-DI
- 00614801001304 FDA UDI
- 510(k) Number
- K093694 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- Rescue blanket, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 33 Inch FDA UDIHeight — 19 Inch FDA UDI
Category: Rescue blanket, reusable
Geratherm Medical Warming Systems by R.g. Enterprises (u.s.a.), Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rescue blanket, reusable.
- MedSource Blanket — MEDSOURCE INTERNATIONAL LLC · Class I
- Rhino Rescue — Wuxi Emsrun Technology Co., Ltd. · Class I
- Elite Mylar Blanket — MEDSOURCE INTERNATIONAL LLC · Class I
- Yellow Emergency Highway Blanket — Dynarex Corp. · Class I
- RHINO RESCUE — Wuxi Emsrun Technology Co., Ltd. · Class I
- Master — Dongguan Maisite Medical Instruments Co., Ltd. · Class I
- MedSource Emergency Blanket — MEDSOURCE INTERNATIONAL LLC · Class I
- MedSource Emergency Blanket — MEDSOURCE INTERNATIONAL LLC · Class I
Cleared under the same submission
K093694 also covers:
- Geratherm Medical Warming Systems — R.G. ENTERPRISES (U.S.A.), INC.
- Medical Warming Systems — R.G. ENTERPRISES (U.S.A.), INC.
- Medical Warming Systems — R.G. ENTERPRISES (U.S.A.), INC.
- Medical Warming Systems — R.G. ENTERPRISES (U.S.A.), INC.
- Medical Warming Systems — R.G. ENTERPRISES (U.S.A.), INC.
- Medical Warming Systems — R.G. ENTERPRISES (U.S.A.), INC.
- Medical Warming Systems — R.G. ENTERPRISES (U.S.A.), INC.
- Medical Warming Systems — R.G. ENTERPRISES (U.S.A.), INC.
- Medical Warming Systems — R.G. ENTERPRISES (U.S.A.), INC.
- Medical Warming Systems — R.G. ENTERPRISES (U.S.A.), INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- R.g. Enterprises (u.s.a.), Inc.
Sources (1)
- FDA UDI 3d224447-90a9-4eb0-bf5d-2b4b1ba02887 38 fields · synced May 30, 2026