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Fora

FDA UDI

Class II (US FDA UDI)

by Fora Care Inc.

Identity

Trade Name
FORA FDA UDI
Generic Name
Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
Device Name
Multi-Functional Monitoring System (Blood Glucose Set) FDA UDI
Model / Reference
6 Connect FDA UDI
Description
Multi-Functional Monitoring System (Blood Glucose Set) FDA UDI

Identifiers

Primary DI / UDI-DI
00816042013904 FDA UDI
FDA Product Code
NBW FDA UDI
GMDN Term
Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple clinical chemistry analyte monitoring system IVD, home-use

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

Similar devices

Also classified as Multiple clinical chemistry analyte monitoring system IVD, home-use.

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 489912d2-7ba0-4850-9a47-b617244bb894 33 fields · synced May 30, 2026