Catalog Number

-

Brand Name

Dialyzer Dialysate QD to 3/8 in.NPT

Version/Model Number

D300-0108

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

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

-

Product Code

MON

Product Code Name

System, Hemodialysis, Remote Accessories

Public Device Record Key

088dff46-8800-4313-a660-eef4172ede95

Public Version Date

September 09, 2019

Public Version Number

1

DI Record Publish Date

August 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-