Catalog Number

ASK-04001-UH

Brand Name

ARROW

Version/Model Number

IPN036396

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

Yes

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

-

FDA Premarket Submission

K862056,K862056

Product Code

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Public Device Record Key

a40a4cdc-aae8-46ff-be82-0ce7d801b396

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

30801902109539

Quantity per Package

5

Contains DI Package

00801902109538

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case