Catalog Number

47700

Brand Name

Halyard

Version/Model Number

47700

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

K823078,K823078,K823078

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

2fc76e3d-c105-4328-ba1d-6f2a54b722d3

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

March 17, 2016

Package DI Number

30680651477003

Quantity per Package

6

Contains DI Package

20680651477006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS