Catalog Number

-

Brand Name

Veraseal 2 Full Face Vented Mask, Extra Large

Version/Model Number

50830

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

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

b38df4ae-4995-4869-b24e-48dc259313dd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2015

Package DI Number

00814747020111

Quantity per Package

10

Contains DI Package

10814747020118

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case