Catalog Number

-

Brand Name

Hemoflow™

Version/Model Number

0500164A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 04, 2020

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)

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

9a417d6a-a81c-4517-a040-ab784a5c0f54

Public Version Date

August 12, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

10840861100047

Quantity per Package

12

Contains DI Package

00840861100040

Package Discontinue Date

March 04, 2020

Package Status

Not in Commercial Distribution

Package Type

-