Catalog Number

-

Brand Name

MedSource Glucose Meter, DS-A

Version/Model Number

MS-76010

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

K082965

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

cff8f264-bc6f-4865-918d-8a9271670424

Public Version Date

July 21, 2021

Public Version Number

4

DI Record Publish Date

July 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-