Catalog Number

BLNE76M

Brand Name

Halyard

Version/Model Number

BLNE76M_0002

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OJG

Product Code Name

Neurological tray

Public Device Record Key

6e2e7155-5479-4e1f-a8ac-fe658b031733

Public Version Date

July 15, 2022

Public Version Number

1

DI Record Publish Date

July 07, 2022

Package DI Number

20809160376079

Quantity per Package

4

Contains DI Package

10809160376072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-