Identity
- Trade Name
- Infa-Therm Mattress FDA UDI
- Generic Name
- Exothermic heat therapy pack/patch FDA UDI
- Device Name
- Infa-Therm Infant Warming Mattress FDA UDI
- Model / Reference
- 1015 FDA UDI
- Description
- Infa-Therm Infant Warming Mattress FDA UDI
Identifiers
- Catalog Number
- 1015 FDA UDI
- Primary DI / UDI-DI
- 00850018561587 FDA UDI
- 510(k) Number
- K221653 FDA UDI
- FDA Product Code
- IMD FDA UDI
- GMDN Term
- Exothermic heat therapy pack/patch 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Exothermic heat therapy pack/patch
Infa-Therm Mattress by International Biomedical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- International Biomedical, Ltd.
Sources (1)
- FDA UDI 62a4a2db-394a-4fd1-9a22-d29726295c1b 35 fields · synced May 30, 2026