Catalog Number

-

Brand Name

Tempo

Version/Model Number

343264

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

-

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

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

5d80ded4-677d-4e81-83b0-04b56a3248b7

Public Version Date

February 25, 2021

Public Version Number

1

DI Record Publish Date

February 17, 2021

Package DI Number

10885325001386

Quantity per Package

70

Contains DI Package

00885325001389

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case Carton