Catalog Number

181A463

Brand Name

AVANOS

Version/Model Number

48122

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

d923b997-df61-4505-96f0-ec9db0c1400c

Public Version Date

December 30, 2019

Public Version Number

1

DI Record Publish Date

December 20, 2019

Package DI Number

10193493481221

Quantity per Package

10

Contains DI Package

00193493481224

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-