Catalog Number

005-1032-HAA

Brand Name

AB5000

Version/Model Number

AB Pump Set 10mm/32x2 Atrial (Hem)

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"

-

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

P900023

Product Code

DSQ

Product Code Name

Ventricular (Assisst) Bypass

Public Device Record Key

1bfd1f9d-f34b-4d01-9090-1ce58d981c3c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 31, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-