Identity
- Trade Name
- HotDog Universal Warming Blanket FDA UDI
- Generic Name
- Electric pad whole-body heating system FDA UDI
- Device Name
- HotDog Universal Warming Blanket FDA UDI
- Model / Reference
- B500 FDA UDI
- Description
- HotDog Universal Warming Blanket FDA UDI
Identifiers
- Catalog Number
- B500 FDA UDI
- Primary DI / UDI-DI
- 00855913001992 FDA UDI
- 510(k) Number
- K112488 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- Electric pad whole-body heating system 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electric pad whole-body heating system
HotDog Universal Warming Blanket by Augustine Temperature Management, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112488 also covers:
- Hillrom powered by Augustine Surgical HD — Augustine Temperature Management, LLC
- Hillrom powered by Augustine Surgical HD — Augustine Temperature Management, LLC
- Hillrom powered by Augustine Surgical HD — Augustine Temperature Management, LLC
- Hillrom powered by Augustine Surgical HD — Augustine Temperature Management, LLC
- Hot Dog Lower Body Warming Blanket, Pediatric — Augustine Temperature Management, LLC
- Hot Dog Pediatric Head Warming Wrap, Large — Augustine Temperature Management, LLC
- Hot Dog Pediatric Head Warming Wrap, Small — Augustine Temperature Management, LLC
- Hot Dog Pediatric Underbody Warming Mattress — Augustine Temperature Management, LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Augustine Temperature Management, LLC
Sources (1)
- FDA UDI 2155f7f3-1792-41b4-9312-3aec3e0d2938 36 fields · synced Jun 9, 2026