Catalog Number

157

Brand Name

AVANOS

Version/Model Number

93821

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

K102483,K102483

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Public Device Record Key

3d03fe42-f30f-43e7-9f1f-4469327c351f

Public Version Date

March 05, 2020

Public Version Number

1

DI Record Publish Date

February 26, 2020

Package DI Number

10609038938216

Quantity per Package

25

Contains DI Package

00609038938219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS