Catalog Number

47578

Brand Name

Halyard

Version/Model Number

47578

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

c4efadea-eef9-4e98-be19-dfe8b04f518d

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

May 13, 2019

Package DI Number

30680651475788

Quantity per Package

6

Contains DI Package

20680651475781

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS