Catalog Number

US5062

Brand Name

A.M.G. PMP Sterile

Version/Model Number

A.M.G. Module PMP NO T.P. Sterile

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

-

Product Code

DTZ

Product Code Name

Oxygenator, Cardiopulmonary Bypass

Public Device Record Key

7ffac85d-32fd-435e-857d-f6dc3a93fba8

Public Version Date

October 26, 2020

Public Version Number

6

DI Record Publish Date

February 28, 2017

Package DI Number

08034013782037

Quantity per Package

1

Contains DI Package

08034013782020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-