Catalog Number

191058

Brand Name

Crit-Line®

Version/Model Number

191058

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

K160749,K160749,K160749

Product Code

KOC

Product Code Name

ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Public Device Record Key

a8ddb937-dbba-418b-9437-b2d69f5b11aa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 04, 2016

Package DI Number

10840861102027

Quantity per Package

36

Contains DI Package

00840861102020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box