Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- External circulating-air core temperature regulation system pad, single-use FDA UDI
- Device Name
- CTEMP, BLANKET, PEDIATRIC UNDERBODY FDA UDI
- Model / Reference
- CTBLANKET555 FDA UDI
- Description
- CTEMP, BLANKET, PEDIATRIC UNDERBODY FDA UDI
Identifiers
- Catalog Number
- CTBLANKET555 FDA UDI
- Primary DI / UDI-DI
- 10193489134780 FDA UDI
- 510(k) Number
- K231211 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- External circulating-air core temperature regulation system pad, single-use 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: External circulating-air core temperature regulation system pad, single-use
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K231211 also covers:
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE 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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 5b487a02-c2dd-4bc1-ba0e-8bb3b06d5739 37 fields · synced Jun 1, 2026