Catalog Number

AK-04550-S

Brand Name

ARROW

Version/Model Number

IPN033865

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

K810962,K810962

Product Code

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Public Device Record Key

16e440b9-312c-4910-8ee0-858a9e11b862

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

June 30, 2017

Package DI Number

10801902067330

Quantity per Package

5

Contains DI Package

20801902067337

Package Discontinue Date

June 27, 2017

Package Status

Not in Commercial Distribution

Package Type

Case