Catalog Number

08053774001

Brand Name

ACCU-CHEK GUIDE

Version/Model Number

08053774001

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160944

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

af047b7d-a7f7-48af-9ee8-cfbe6d9a0dc0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-