Catalog Number

22716-5

Brand Name

AVANOS

Version/Model Number

98977

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

938f6f70-e1e8-422c-ad4b-437f56933680

Public Version Date

April 03, 2020

Public Version Number

1

DI Record Publish Date

March 26, 2020

Package DI Number

20609038989772

Quantity per Package

2

Contains DI Package

10609038989775

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS