Catalog Number

-

Brand Name

GoodFeeling Disposable Medical Face Mask (non-sterile)

Version/Model Number

GFYC01

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

QKR

Product Code Name

Face Mask Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health Emergency

Public Device Record Key

80f9f6b9-4507-4335-9c99-83cb26ef9125

Public Version Date

May 17, 2021

Public Version Number

1

DI Record Publish Date

May 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-