Catalog Number

05919983160

Brand Name

Accu-Chek Compact Plus

Version/Model Number

05919983160

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

K113614,K113614,K113614

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

06a16ddc-28a9-4d23-a899-64e772e42a35

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 26, 2016

Package DI Number

10075537927141

Quantity per Package

48

Contains DI Package

00075537927144

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-