Catalog Number

-

Brand Name

Tempo

Version/Model Number

343105

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K192859,K192859,K192859,K192859

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

a5c4dd2d-ec41-41eb-8cbe-b5f31877c498

Public Version Date

February 25, 2021

Public Version Number

1

DI Record Publish Date

February 17, 2021

Package DI Number

10885325001423

Quantity per Package

35

Contains DI Package

00885325001426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack