Catalog Number

1942FB

Brand Name

ESPE™

Version/Model Number

1942FB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 09, 2025

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)

Yes

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

82de17eb-0c53-478a-886a-d528dd6295bb

Public Version Date

April 11, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

50605861032310

Quantity per Package

12

Contains DI Package

30605861032316

Package Discontinue Date

April 09, 2022

Package Status

Not in Commercial Distribution

Package Type

BOX