Catalog Number

BLGY18K

Brand Name

Halyard

Version/Model Number

BLGY18K_0004

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

OKV

Product Code Name

Obstetrical kit

Public Device Record Key

55c7fa61-689b-448c-8df6-c92a8ed33035

Public Version Date

October 04, 2022

Public Version Number

1

DI Record Publish Date

September 26, 2022

Package DI Number

20809160386412

Quantity per Package

4

Contains DI Package

10809160386415

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-