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TempTraq

FDA UDI

Class II (US FDA UDI)

by Blue Spark Technologies, Inc.

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
601 FDA UDI
Primary DI / UDI-DI
00851203006012 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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wireless patient thermometer, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI cb69d621-4c55-46a9-a5b8-04fd956b0c5e 36 fields · synced Jun 8, 2026