Catalog Number

-

Brand Name

Care Touch

Version/Model Number

CT-50

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

K111456,K111456,K111456

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

081df9ce-3f6c-4477-98ac-cc8d0515732a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 05, 2018

Package DI Number

10370393211053

Quantity per Package

425

Contains DI Package

00370393211056

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-