Catalog Number

429000

Brand Name

KENAFLEXX

Version/Model Number

429000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

3dd74ee8-78ba-49ee-ae93-f32bed30b0c2

Public Version Date

May 19, 2020

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

10852244007140

Quantity per Package

100

Contains DI Package

00852244007143

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE