Catalog Number

1157

Brand Name

AVANOS

Version/Model Number

93880

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BYD

Product Code Name

CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Public Device Record Key

2fa1abed-3f86-47c8-b303-b24695f407a9

Public Version Date

March 05, 2020

Public Version Number

1

DI Record Publish Date

February 26, 2020

Package DI Number

10609038938803

Quantity per Package

50

Contains DI Package

00609038938806

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS