Catalog Number

-

Brand Name

FORA

Version/Model Number

V12/Premium V12/Premium V12 Voice

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090536,K090536

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

3bdca7a2-a328-46b9-bb34-019ed39d4cf7

Public Version Date

November 09, 2020

Public Version Number

3

DI Record Publish Date

July 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-