Identity
- Trade Name
- CIRCA Temperature Monitoring System FDA UDI
- Generic Name
- Continuous electronic patient thermometer, line-powered FDA UDI
- Model / Reference
- CS-1000 (SW Ver 3.0) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851498007152 FDA UDI
- 510(k) Number
- K222311 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Continuous electronic patient thermometer, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
CIRCA Temperature Monitoring System by CIRCA Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K222311 also covers:
- CIRCA Temperature Cable — CIRCA Scientific, Inc.
- CIRCA Temperature Monitoring System — CIRCA Scientific, Inc.
- CIRCA Temperature Monitoring System — CIRCA Scientific, Inc.
- CIRCA Temperature Monitoring System — CIRCA Scientific, Inc.
- CIRCA Temperature Standard — CIRCA Scientific, Inc.
- MATRIX12 M Esophageal Temperature Probe — CIRCA Scientific, 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 |
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Manufacturer
- Manufacturer
- CIRCA Scientific, Inc.
Sources (1)
- FDA UDI 62254a95-fbb2-4a76-b6c1-5e5e04d68bb1 34 fields · synced Jun 9, 2026