Catalog Number

-

Brand Name

Veraseal 3 Full Face Non Vented Mask, Large

Version/Model Number

50951

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

8ec79168-38af-4d14-99bd-4163ad74bdd7

Public Version Date

December 13, 2019

Public Version Number

2

DI Record Publish Date

May 03, 2019

Package DI Number

10814747021511

Quantity per Package

10

Contains DI Package

00814747021514

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case