Catalog Number

-

Brand Name

D-Care

Version/Model Number

50001A

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132086,K132086,K132086

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

75b15c0f-4f54-42d8-b4af-e46e5e1024e4

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

July 24, 2017

Package DI Number

20370914001009

Quantity per Package

40

Contains DI Package

00370914001005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case