Catalog Number

-

Brand Name

Dialysate Port Cap 1"

Version/Model Number

7000-0007

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

ebd79959-85ab-49f2-8d04-1b1d12f03a90

Public Version Date

September 03, 2019

Public Version Number

1

DI Record Publish Date

August 26, 2019

Package DI Number

10858293006233

Quantity per Package

100

Contains DI Package

00858293006236

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag