Identity
- Trade Name
- Hot Dog Underbody Warming Mattress, 127 cm (50in) FDA UDI
- Generic Name
- Electric pad whole-body heating system FDA UDI
- Device Name
- Labeled: Hot Dog Underbody Warming Mattress, 127 cm (50 in) U102 FDA UDI
- Model / Reference
- U102 FDA UDI
- Description
- Labeled: Hot Dog Underbody Warming Mattress, 127 cm (50 in) U102 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855913001527 FDA UDI
- 510(k) Number
- K092807 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
No
FDA UDI
Category: Electric pad whole-body heating system
Hot Dog Underbody Warming Mattress, 127 cm (50in) by Augustine Temperature Management, LLC — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K092807 also covers:
- Hot Dog Trendelenburg Warming Mattress, 89 cm (35in) — Augustine Temperature Management, LLC
- Hot Dog Underbody Warming Mattress, 82 cm (32in) — Augustine Temperature Management, LLC
- Waffle Grip Trendelenburg Positioning System a Hot Dog Patient Warming Accessory — Augustine Temperature Management, LLC
- DeRoyal — DEROYAL INDUSTRIES, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Augustine Temperature Management, LLC
Sources (1)
- FDA UDI 097022d6-5c3c-441b-8a50-a2c0bc2ec651 35 fields · synced Jun 9, 2026