Catalog Number

04541057001

Brand Name

Accu-Chek Rapid-D Link

Version/Model Number

04541057001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 23, 2018

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

4480d63f-278c-4a3b-b0a7-ba74576b1e27

Public Version Date

April 29, 2019

Public Version Number

4

DI Record Publish Date

August 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-