Catalog Number

-

Brand Name

Indiana Face Mask

Version/Model Number

IFM-SM3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K202214,K202214,K202214

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

937ab1e1-44bf-4b4e-8593-371596ceb9a7

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

Package DI Number

B959IFMSM31

Quantity per Package

10

Contains DI Package

B959IFMSM30

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case