Catalog Number

0342501

Brand Name

CAREline

Version/Model Number

0342501

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"

Yes

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

K172238,K172238

Product Code

FJK

Product Code Name

SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Public Device Record Key

49a4595b-9000-4438-a79a-5dd3013f5434

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

April 17, 2018

Package DI Number

10840861100412

Quantity per Package

28

Contains DI Package

00840861100415

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

null