Catalog Number

-

Brand Name

Chech Valve - 3 grams - Dialysate

Version/Model Number

H100-0003

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MON

Product Code Name

System, Hemodialysis, Remote Accessories

Public Device Record Key

3296016c-ebaa-4d54-b65f-49aec93b2106

Public Version Date

September 05, 2019

Public Version Number

1

DI Record Publish Date

August 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-