Catalog Number

181A478

Brand Name

AVANOS

Version/Model Number

181A478

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

K941153,K941153

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Public Device Record Key

db469263-616d-4a12-9bbd-8e4b55f2a5c0

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 20, 2020

Package DI Number

10193493000439

Quantity per Package

20

Contains DI Package

00193493000432

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS