Catalog Number

05391512001

Brand Name

Accu-Chek Combo

Version/Model Number

05391512001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 17, 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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LZG

Product Code Name

Pump, Infusion, Insulin

Public Device Record Key

1f0af788-c5c8-4790-b1be-39f577975e9a

Public Version Date

September 20, 2021

Public Version Number

3

DI Record Publish Date

August 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-