Catalog Number

-

Brand Name

IV Administration Set

Version/Model Number

11221

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

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

c8909f2b-ff41-4743-8308-eff53d500f7b

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

August 01, 2019

Package DI Number

30369771000215

Quantity per Package

50

Contains DI Package

00369771000214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner