Catalog Number

0006004.000

Brand Name

MOX/RM3 Battery

Version/Model Number

MOX/RM3 Battery

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K971571

Product Code

KDN

Product Code Name

System, Perfusion, Kidney

Public Device Record Key

e04eaff5-e68e-4d8b-823b-c445ce184731

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

February 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-