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Fora

FDA UDI

Class II (US FDA UDI)

by Fora Care Inc.

Identity

Trade Name
FORA FDA UDI
Generic Name
General-purpose patient temperature probe, single-use FDA UDI
Device Name
Ear Thermometer Probe Cover FDA UDI
Model / Reference
IR20 FDA UDI
Description
Ear Thermometer Probe Cover FDA UDI

Identifiers

Primary DI / UDI-DI
00898939002253 FDA UDI
510(k) Number
K090395 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

No

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

No

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

Fora by Fora Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K090395 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fora Care Inc.

Sources (1)

  • FDA UDI f74d20df-7c23-4f27-ad9a-e927b0979091 34 fields · synced Jun 1, 2026