Catalog Number

IAK-S8IT

Brand Name

ARROW

Version/Model Number

IPN915328

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

K981660,K981660

Product Code

DSP

Product Code Name

System, balloon, intra-aortic and control

Public Device Record Key

59160c3f-4c88-4cf4-9277-9149b015b7cc

Public Version Date

September 23, 2021

Public Version Number

1

DI Record Publish Date

September 15, 2021

Package DI Number

10801902162004

Quantity per Package

1

Contains DI Package

20801902162001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box