Catalog Number

ASK-04000-HMC

Brand Name

ARROW

Version/Model Number

IPN916982

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,K862056

Product Code

DQY

Product Code Name

Catheter, percutaneous

Public Device Record Key

87edbf16-51ac-4c14-9b60-e2a1f30980fb

Public Version Date

April 07, 2022

Public Version Number

1

DI Record Publish Date

March 30, 2022

Package DI Number

40801902167307

Quantity per Package

10

Contains DI Package

30801902167300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case