Catalog Number

CL10041021

Brand Name

Crit-Line®

Version/Model Number

CL10041021

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

-

Product Code

KOC

Product Code Name

ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Public Device Record Key

7edb415a-77e2-41aa-9d2f-e66f72137f02

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 19, 2015

Package DI Number

10840861100559

Quantity per Package

36

Contains DI Package

00840861100552

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box