Catalog Number

BRYN027-01

Brand Name

Halyard

Version/Model Number

BRYN027-01_0008

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

HFW

Product Code Name

Clamp, umbilical

Public Device Record Key

2c4ea58e-13dd-45ec-bcf5-e4d547cd2aa2

Public Version Date

December 18, 2020

Public Version Number

1

DI Record Publish Date

December 10, 2020

Package DI Number

20809160306083

Quantity per Package

100

Contains DI Package

10809160306086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-