Catalog Number

18933

Brand Name

AVANOS

Version/Model Number

18933

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

26baca01-af36-4f1b-a007-456f69083c39

Public Version Date

December 13, 2021

Public Version Number

3

DI Record Publish Date

September 25, 2019

Package DI Number

10193493924162

Quantity per Package

25

Contains DI Package

00193493924165

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS