Catalog Number

-

Brand Name

IV Administration Set Needlefree

Version/Model Number

036211274000

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

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

c88cd5f8-79a4-4b3e-ad24-d10fd89c3619

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

January 01, 2019

Package DI Number

20853620005313

Quantity per Package

4

Contains DI Package

10853620005316

Package Discontinue Date

April 02, 2020

Package Status

Not in Commercial Distribution

Package Type

-