Catalog Number

35169

Brand Name

AVANOS

Version/Model Number

35169

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

K080821,K080821

Product Code

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Public Device Record Key

d9863ffc-afd3-4c95-a120-8545ba5519fa

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 01, 2020

Package DI Number

10609038351695

Quantity per Package

10

Contains DI Package

00609038351698

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS