Catalog Number

2270135-4J

Brand Name

AVANOS

Version/Model Number

99405

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

3f2af7e0-8292-4e10-8fea-74812f8376ba

Public Version Date

May 15, 2020

Public Version Number

1

DI Record Publish Date

May 07, 2020

Package DI Number

20609038994059

Quantity per Package

2

Contains DI Package

10609038994052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS