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Novatemp

FDA UDI

Class II (US FDA UDI)

by Novamed-Usa

Identity

Trade Name
NOVATEMP FDA UDI
Generic Name
General-purpose patient temperature probe, single-use FDA UDI
Device Name
SKIN TEMPERATURE SENSOR WITH 400 SERIES THERMISTOR FDA UDI
Model / Reference
10-1600-001 FDA UDI
Description
SKIN TEMPERATURE SENSOR WITH 400 SERIES THERMISTOR FDA UDI

Identifiers

Primary DI / UDI-DI
00817499020040 FDA UDI
FDA Product Code
FLL FDA UDI
GMDN Term
General-purpose patient temperature probe, 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

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

No

FDA UDI

Category: General-purpose patient temperature probe, single-use

Novatemp by Novamed-Usa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose patient temperature probe, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novamed-Usa

Sources (1)

  • FDA UDI 9c528d6e-09a3-4f03-8840-e2fe44ed8dc4 33 fields · synced Jun 8, 2026