Catalog Number

-

Brand Name

Choice

Version/Model Number

8000-10630

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

-

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

344fcb10-0323-4551-b5fb-1dc3a6a1c566

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 07, 2018

Package DI Number

20860418002645

Quantity per Package

12

Contains DI Package

00860418002641

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper