Catalog Number

ASK-12703-HM1

Brand Name

ARROW

Version/Model Number

IPN037666

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

b3252fd2-808a-4ff0-85d6-27242baff4a1

Public Version Date

June 18, 2021

Public Version Number

9

DI Record Publish Date

November 11, 2016

Package DI Number

20816000013742

Quantity per Package

5

Contains DI Package

10816000013745

Package Discontinue Date

June 16, 2021

Package Status

Not in Commercial Distribution

Package Type

Case