Catalog Number

7204001

Brand Name

Diacap®

Version/Model Number

7204001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 09, 2019

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)

Yes

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

5a1b4197-0686-4cb2-b4f5-69089e91e8c5

Public Version Date

August 20, 2021

Public Version Number

5

DI Record Publish Date

August 09, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-