BREEZE® 2 - Blood Glucose Test Strips. Sold in a carton of 50 - ASCENSIA DIABETES CARE US INC.

Duns Number:080028910

Device Description: Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).

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More Product Details

Catalog Number

1467A

Brand Name

BREEZE® 2

Version/Model Number

1467A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 10, 2018

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

K062347,K062347,K062347,K062347,K062347

Product Code Details

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Device Record Status

Public Device Record Key

05e1af1c-c8f4-49fd-8dbd-a3ff010f6547

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

40301931467503

Quantity per Package

24

Contains DI Package

00301931467505

Package Discontinue Date

January 10, 2018

Package Status

Not in Commercial Distribution

Package Type

shipper/case

"ASCENSIA DIABETES CARE US INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 19
3 A medical device with high risk that requires premarket approval 2