Catalog Number

05919967160

Brand Name

Accu-Chek Compact Plus

Version/Model Number

05919967160

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 14, 2021

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

447db7cd-477f-45c2-b7a9-78f482c7824e

Public Version Date

January 15, 2021

Public Version Number

4

DI Record Publish Date

August 26, 2016

Package DI Number

10075537598846

Quantity per Package

24

Contains DI Package

00075537598849

Package Discontinue Date

January 14, 2021

Package Status

Not in Commercial Distribution

Package Type

-