Catalog Number

IAH-09046

Brand Name

ARROW

Version/Model Number

IPN001076

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

-

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

K060309,K060309

Product Code

DSP

Product Code Name

System, balloon, intra-aortic and control

Public Device Record Key

bf2ce227-8212-4e85-ac65-c85e27e1487d

Public Version Date

June 10, 2020

Public Version Number

4

DI Record Publish Date

March 10, 2018

Package DI Number

30801902091155

Quantity per Package

1

Contains DI Package

00801902091154

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case