Catalog Number

-

Brand Name

Codan

Version/Model Number

BC 2164

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"

Yes

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

c11d73ed-9d00-4327-ab7e-e4a8e4a45f1d

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

July 31, 2021

Package DI Number

00813153026786

Quantity per Package

1

Contains DI Package

10813153026783

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-