Catalog Number

IAK-07848

Brand Name

ARROW

Version/Model Number

IPN038266

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

-

Product Code

DSP

Product Code Name

System, balloon, intra-aortic and control

Public Device Record Key

f8f366a9-3c5d-49e9-ab9f-262a11eca566

Public Version Date

December 17, 2020

Public Version Number

1

DI Record Publish Date

December 09, 2020

Package DI Number

20801902144212

Quantity per Package

1

Contains DI Package

10801902144215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box