Catalog Number

3900056.001

Brand Name

RM3 Accessory - Filter/Adapter

Version/Model Number

RM3 Accessory - Filter/Adapter

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

Yes

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

1d2569cd-3cbc-4e82-8389-727d10372ddb

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

-