Identity
- Trade Name
- TempTraq FDA UDI
- Generic Name
- Wireless patient thermometer, single-use FDA UDI
- Device Name
- Continuous Temperature Monitor FDA UDI
- Model / Reference
- TT-100 FDA UDI
- Description
- Continuous Temperature Monitor FDA UDI
Identifiers
- Catalog Number
- 602 FDA UDI
- Primary DI / UDI-DI
- 00851203006029 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Wireless patient thermometer, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 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
No
FDA UDI
Over-the-Counter
Yes
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: Wireless patient thermometer, single-use
TempTraq by Blue Spark Technologies, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wireless patient thermometer, single-use.
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- Radius T — MASIMO CORPORATION · Class II
- Radius T — MASIMO CORPORATION · Class II
- TempTraq® — Blue Spark Technologies, Inc. · Class II
- TempTraq® — Blue Spark Technologies, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Blue Spark Technologies, Inc.
Sources (2)
- FDA UDI 7cf21311-00d9-4c35-9a74-9cfa74347663 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026