Catalog Number

182A148

Brand Name

Halyard

Version/Model Number

97846

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)

-

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

5aa72a9d-bb18-49fd-b31b-0cdbebfd3020

Public Version Date

November 16, 2018

Public Version Number

4

DI Record Publish Date

May 25, 2016

Package DI Number

30680651978463

Quantity per Package

10

Contains DI Package

10680651978469

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS