Catalog Number

189A000

Brand Name

Halyard

Version/Model Number

98586

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

K941562,K941562

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

7a55f20c-f9ed-4c77-9a5f-302e8247337e

Public Version Date

November 16, 2018

Public Version Number

4

DI Record Publish Date

January 31, 2016

Package DI Number

30680651985867

Quantity per Package

25

Contains DI Package

10680651985863

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS