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Novatemp

FDA UDI

Class I (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
15mm MYOCARDIAL TEMPERATURE PROBE WITH 400 SERIES THERMISTOR FDA UDI
Model / Reference
10-1650-001 FDA UDI
Description
15mm MYOCARDIAL TEMPERATURE PROBE WITH 400 SERIES THERMISTOR FDA UDI

Identifiers

Primary DI / UDI-DI
00817499020187 FDA UDI
FDA Product Code
KRI FDA UDI
GMDN Term
General-purpose patient temperature probe, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Novatemp by Novamed-Usa — Class I — 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 ccad62be-89c6-4363-bc57-05d58fe91976 34 fields · synced May 30, 2026