CONTOUR® - Control Solution - Low, 1 x 2.5 mL - ASCENSIA DIABETES CARE US INC.

Duns Number:080028910

Device Description: Control Solution - Low, 1 x 2.5 mL

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More Product Details

Catalog Number

7110B

Brand Name

CONTOUR®

Version/Model Number

7110B

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K062058,K090628,K062058,K090628,K062058,K090628,K062058,K090628

Product Code Details

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

6cd1987a-6492-4945-9f3b-efc78c34a192

Public Version Date

December 03, 2018

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

50301937110011

Quantity per Package

32

Contains DI Package

40301937110014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

out.shipper/lg 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