Catalog Number

IAH-09048

Brand Name

ARROW

Version/Model Number

IPN919009

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

ad7f6cb7-fc1a-4964-9ce2-6b86e55af887

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 17, 2021

Package DI Number

20801902179368

Quantity per Package

1

Contains DI Package

10801902179361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box