Catalog Number

0450007

Brand Name

CAREline

Version/Model Number

0450007

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

-

Prescription Use (Rx)

-

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

b8be9e90-d20f-4f01-917b-5626d6cc4c6a

Public Version Date

June 22, 2018

Public Version Number

1

DI Record Publish Date

May 22, 2018

Package DI Number

10840861102072

Quantity per Package

12

Contains DI Package

00840861102075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

null