Identity
- Trade Name
- ThermaCor 1200 Infusion System FDA UDI
- Generic Name
- Conduction blood/fluid warmer FDA UDI
- Device Name
- Drape FDA UDI
- Model / Reference
- TD-1200 FDA UDI
- Description
- Drape FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857893006158 FDA UDI
- 510(k) Number
- K052055 FDA UDI
- FDA Product Code
- FRN FDA UDILGZ FDA UDI
- GMDN Term
- Conduction blood/fluid warmer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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: Conduction blood/fluid warmer
ThermaCor 1200 Infusion System by Smisson-Cartledge Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K052055 also covers:
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, 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 |
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Manufacturer
- Manufacturer
- Smisson-Cartledge Biomedical, LLC
Sources (1)
- FDA UDI 4bc532c7-6ada-4d14-97ae-9c97d79a4af8 35 fields · synced May 30, 2026