Catalog Number

78404000

Brand Name

Renalin

Version/Model Number

78404-000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 25, 2022

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K941439,K941439

Product Code

LRJ

Product Code Name

Disinfectant, Medical Devices

Public Device Record Key

0f46d342-348f-4fb6-83de-c3fd34d8366a

Public Version Date

May 26, 2022

Public Version Number

6

DI Record Publish Date

February 26, 2018

Package DI Number

30677964021825

Quantity per Package

12

Contains DI Package

00677964021824

Package Discontinue Date

May 25, 2022

Package Status

Not in Commercial Distribution

Package Type

Box