Catalog Number

-

Brand Name

Dialysate POrt Caps 1" Bulk

Version/Model Number

7000-0008

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

FJI

Product Code Name

Dialyzer, Capillary, Hollow Fiber

Public Device Record Key

658df9eb-4e93-4cea-8a68-eee124ef57b6

Public Version Date

September 03, 2019

Public Version Number

1

DI Record Publish Date

August 26, 2019

Package DI Number

10858293006240

Quantity per Package

1000

Contains DI Package

00858293006243

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag