Catalog Number

0055-1032-HA

Brand Name

AB5000

Version/Model Number

AB Pump Set 10mm/32 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

52e688f9-867d-4ce8-adfd-f63179bdd082

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

-