Catalog Number

69193

Brand Name

Halyard

Version/Model Number

69193

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

LYU

Product Code Name

ACCESSORY, SURGICAL APPAREL

Public Device Record Key

c1579d7e-5597-4eba-bf33-29668cd17cb1

Public Version Date

January 08, 2021

Public Version Number

1

DI Record Publish Date

December 31, 2020

Package DI Number

30680651691935

Quantity per Package

10

Contains DI Package

20680651691938

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS