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Innovo

FDA UDI

Class II (US FDA UDI)

by Innovo Medical

Identity

Trade Name
Innovo FDA UDI
Generic Name
Infrared patient thermometer, skin FDA UDI
Device Name
Non-contact Digital Infrared Forehead Thermometer FDA UDI
Model / Reference
INV-FR201 FDA UDI
Description
Non-contact Digital Infrared Forehead Thermometer FDA UDI

Identifiers

Catalog Number
M499N-F1WH-JPIM FDA UDI
Primary DI / UDI-DI
00851697006130 FDA UDI
FDA Product Code
FLL FDA UDI
GMDN Term
Infrared patient thermometer, skin 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Infrared patient thermometer, skin

Innovo by Innovo Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infrared patient thermometer, skin.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Innovo Medical

Sources (1)

  • FDA UDI 74231bc4-ea2c-4284-aa6a-33e387d691e6 35 fields · synced Jun 1, 2026