Kroger Premium Blood Glucose Test Strips - Test Strips, Kroger, Premium, 50CT, 100CT - KROGER CO., THE

Duns Number:006999528

Device Description: Test Strips, Kroger, Premium, 50CT, 100CT

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More Product Details

Catalog Number

-

Brand Name

Kroger Premium Blood Glucose Test Strips

Version/Model Number

8000-06762

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Device Record Status

Public Device Record Key

8558dad8-ea04-4ec0-8543-0d9557bbbf03

Public Version Date

December 03, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20041260360705

Quantity per Package

12

Contains DI Package

00041260360701

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper

"KROGER CO., THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 15