Catalog Number

ADVG036-04

Brand Name

Halyard

Version/Model Number

ADVG036-04_0004

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

K961225,K961225

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

2deacc60-c26e-436b-a066-eae87abc15f5

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

December 10, 2020

Package DI Number

20809160303723

Quantity per Package

25

Contains DI Package

10809160303726

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-