Catalog Number

-

Brand Name

Hemoflow™

Version/Model Number

0520165A

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190459,K874872,K190459,K874872

Product Code

FJI

Product Code Name

DIALYZER, CAPILLARY, HOLLOW FIBER

Public Device Record Key

702312f4-d0d2-4c08-b213-da644813e133

Public Version Date

December 21, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2015

Package DI Number

10840861100016

Quantity per Package

15

Contains DI Package

00840861100019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-