Catalog Number

78336000

Brand Name

Renalin

Version/Model Number

78336-000

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

cd3f5a07-d369-403e-922a-0ebb25bf5e40

Public Version Date

May 26, 2022

Public Version Number

6

DI Record Publish Date

February 26, 2018

Package DI Number

30677964000288

Quantity per Package

12

Contains DI Package

00677964000287

Package Discontinue Date

May 25, 2022

Package Status

Not in Commercial Distribution

Package Type

Box