Catalog Number

104172

Brand Name

INTERNAL RECHARGEABLE NIMH BATTERY PACK FOR CENTRIMAG PRIMARY CONSOLE

Version/Model Number

104172

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

-

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

DWA

Product Code Name

Control, Pump Speed, Cardiopulmonary Bypass

Public Device Record Key

26e5f49a-d833-4338-89f6-b1a12f6d97c2

Public Version Date

February 06, 2019

Public Version Number

5

DI Record Publish Date

September 20, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-