Catalog Number

AK-04150-E-S

Brand Name

ARROW

Version/Model Number

IPN032619

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K820009,K820009

Product Code

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Public Device Record Key

8fbf21ec-7f40-475a-abdb-6dd9bdbc5cfa

Public Version Date

March 05, 2021

Public Version Number

11

DI Record Publish Date

September 16, 2016

Package DI Number

30801902067310

Quantity per Package

5

Contains DI Package

00801902067319

Package Discontinue Date

March 01, 2021

Package Status

Not in Commercial Distribution

Package Type

Case