Catalog Number

H9386109EN

Brand Name

AVANOS

Version/Model Number

H9386109EN

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KYX

Product Code Name

DISPENSER, LIQUID MEDICATION

Public Device Record Key

f380bffd-a2bf-4ef9-b3f3-104400e11b75

Public Version Date

May 21, 2021

Public Version Number

1

DI Record Publish Date

May 13, 2021

Package DI Number

10350770003099

Quantity per Package

16

Contains DI Package

00350770003092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS