Catalog Number

ASK-04000-HMC

Brand Name

ARROW

Version/Model Number

IPN032681

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

K862056,K862056

Product Code

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Public Device Record Key

9ffeda55-cf8d-4832-aa47-be2cf8a607da

Public Version Date

February 22, 2022

Public Version Number

9

DI Record Publish Date

September 16, 2016

Package DI Number

30801902052781

Quantity per Package

10

Contains DI Package

00801902052780

Package Discontinue Date

February 17, 2022

Package Status

Not in Commercial Distribution

Package Type

Case