Meijer Essential Blood Glucose Test Strips - Test Strips, Meijer, Essential, 25CT - MEIJER, INC.

Duns Number:006959555

Device Description: Test Strips, Meijer, Essential, 25CT

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More Product Details

Catalog Number

-

Brand Name

Meijer Essential Blood Glucose Test Strips

Version/Model Number

8000-10412

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 19, 2019

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

832fc7b8-fd08-4525-8721-27a9b36618a8

Public Version Date

June 20, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10713733070321

Quantity per Package

24

Contains DI Package

00713733070324

Package Discontinue Date

February 19, 2019

Package Status

Not in Commercial Distribution

Package Type

Shipper

"MEIJER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 45
U Unclassified 1