Catalog Number

FIS4-45-10

Brand Name

Fountain®

Version/Model Number

00884450025475

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KRA

Product Code Name

Catheter, continuous flush

Public Device Record Key

03505d03-e0c9-4c88-a903-a0d3e6a15521

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

September 22, 2016

Package DI Number

10884450025472

Quantity per Package

5

Contains DI Package

00884450025475

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-