Catalog Number

181A465

Brand Name

AVANOS

Version/Model Number

48127

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

c17d7b1f-45ec-4af3-b930-cda41f44512c

Public Version Date

November 25, 2019

Public Version Number

1

DI Record Publish Date

November 15, 2019

Package DI Number

10193493481276

Quantity per Package

20

Contains DI Package

00193493481279

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-