Catalog Number

-

Brand Name

DualGuard Endoscopy Mouthpiece Adult

Version/Model Number

032-10-870U

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"

-

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

K140473

Product Code

CAT

Product Code Name

Cannula, Nasal, Oxygen

Public Device Record Key

30912c13-70e9-4cac-8413-4721d6df3d7d

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

December 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-