Catalog Number

04-9006-5

Brand Name

Fresenius

Version/Model Number

04-9006-5

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

K010268,K010268

Product Code

KOC

Product Code Name

ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Public Device Record Key

809619ed-b2f1-4eee-a016-d27d0ac9e280

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 30, 2015

Package DI Number

10840861100511

Quantity per Package

100

Contains DI Package

00840861100514

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-