Identity
- Trade Name
- Infant Heel Warmer FDA UDI
- Generic Name
- Activated-medium surgical warming blanket FDA UDI
- Device Name
- Infant Heel Warmer FDA UDI
- Model / Reference
- 1223 FDA UDI
- Description
- Infant Heel Warmer FDA UDI
Identifiers
- Catalog Number
- 1223 FDA UDI
- Primary DI / UDI-DI
- 00850018561594 FDA UDI
- 510(k) Number
- K221154 FDA UDI
- FDA Product Code
- MPO FDA UDI
- GMDN Term
- Activated-medium surgical warming blanket FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5710 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Activated-medium surgical warming blanket
Infant Heel Warmer by International Biomedical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Activated-medium surgical warming blanket.
- WARMGEL INSTANT HEAT PACK - Medium — CooperSurgical, Inc. · Class I
- FORWARD HEAT - Life Guard — INTEGRATED MEDCRAFT LLC · Class I
- Barrier® EasyWarm® — Mölnlycke Health Care AB · Class II
- FORWARD HEAT - Emergency Blanket — INTEGRATED MEDCRAFT LLC · Class I
- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
- NAR — NORTH AMERICAN RESCUE, LLC.
- Infant Heel Snuggler — INTERNATIONAL BIOMEDICAL, LTD. · Class I
Cleared under the same submission
K221154 also covers:
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- International Biomedical, Ltd.
Sources (1)
- FDA UDI a91123b6-aed8-4c1b-9be2-a35da18f8702 35 fields · synced Jun 8, 2026