Catalog Number

-

Brand Name

Halyard

Version/Model Number

79042

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OKH

Product Code Name

Body fluids barrier kit

Public Device Record Key

7d382c19-f43e-4b6e-ae98-df66d5619ee1

Public Version Date

October 22, 2019

Public Version Number

1

DI Record Publish Date

October 14, 2019

Package DI Number

20809160266882

Quantity per Package

12

Contains DI Package

10809160266885

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-