Catalog Number

-

Brand Name

Insta/Vent - Safe-T-Shield Mouthpiece

Version/Model Number

MNMP500-NC

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

Yes

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

BYP

Product Code Name

Mouthpiece, Breathing

Public Device Record Key

d93f89c7-3312-4069-b6bd-373e42153cab

Public Version Date

April 26, 2022

Public Version Number

1

DI Record Publish Date

April 18, 2022

Package DI Number

00850022357718

Quantity per Package

20

Contains DI Package

00850022357701

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-