Identity
- Trade Name
- Snuggle Warm, Adult Underbody Convective Warming Blanket with Arm Openings EUDAMEDLevel 1 FDA UDI
- Generic Name
- External circulating-air core temperature regulation system pad, single-use FDA UDI
- Device Name
- Snuggle Warm Patient Warming Blankets EUDAMED
- Model / Reference
- SWU-2113 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 10610586043475 EUDAMEDFDA UDI
- Basic UDI-DI
- 0610586M0079DK EUDAMED
- 510(k) Number
- K141686 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- EMDN Code
- Z12040208 BODY THERMOREGULATION EQUIPMENT EUDAMED
- GMDN Term
- External circulating-air core temperature regulation system pad, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5900 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: External circulating-air core temperature regulation system pad, single-use
Level 1 by Icu Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as External circulating-air core temperature regulation system pad, single-use.
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Cleared under the same submission
K141686 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (2)
- FDA UDI 0b96e666-5cb9-4f7e-b186-afd1daf7326f 33 fields · synced Aug 3, 2026
- EUDAMED dfeb8167-deec-4ea4-86b9-15a2ea97e8a6 61 fields · synced Aug 3, 2026