Catalog Number

2-025

Brand Name

AVANOS

Version/Model Number

99324

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

BSY

Product Code Name

CATHETERS, SUCTION, TRACHEOBRONCHIAL

Public Device Record Key

bdfe1043-da76-4427-be3f-16cedb898607

Public Version Date

June 29, 2020

Public Version Number

1

DI Record Publish Date

June 20, 2020

Package DI Number

10609038993246

Quantity per Package

20

Contains DI Package

00609038993249

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS