Catalog Number

1978127

Brand Name

AVANOS

Version/Model Number

94683

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"

Yes

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

BSY

Product Code Name

CATHETERS, SUCTION, TRACHEOBRONCHIAL

Public Device Record Key

864071b3-a294-40b2-acd5-80f4b6eb3615

Public Version Date

June 16, 2020

Public Version Number

1

DI Record Publish Date

June 08, 2020

Package DI Number

10609038946839

Quantity per Package

20

Contains DI Package

00609038946832

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS