Catalog Number

06594000001

Brand Name

Accu-Chek Ultraflex

Version/Model Number

06594000001

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

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

K122686,K122686

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

bdb42ac6-78ba-49de-809f-5a6e2b188d5f

Public Version Date

January 15, 2021

Public Version Number

5

DI Record Publish Date

August 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-