Catalog Number

-

Brand Name

Health Line

Version/Model Number

KIT-420-41

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

-

Product Code

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Public Device Record Key

723d986d-d202-4881-8b70-09252718fbb4

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

February 11, 2017

Package DI Number

10876604000435

Quantity per Package

5

Contains DI Package

00876604000438

Package Discontinue Date

-

Package Status

-

Package Type

Inner