Catalog Number

79002

Brand Name

Halyard

Version/Model Number

79002

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

-

Product Code

FME

Product Code Name

Gown, examination

Public Device Record Key

448d21ba-1c65-4cb4-af6c-d32f6cad46ef

Public Version Date

January 08, 2021

Public Version Number

1

DI Record Publish Date

December 31, 2020

Package DI Number

30680651790027

Quantity per Package

1

Contains DI Package

20680651790020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS