Catalog Number

Not Applicable

Brand Name

MedSource Airway Devices

Version/Model Number

MS-238100

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

CAE

Product Code Name

Airway, Oropharyngeal, Anesthesiology

Public Device Record Key

1a087b6e-4d9a-4cc1-a462-e46ada40a0df

Public Version Date

December 07, 2021

Public Version Number

1

DI Record Publish Date

November 29, 2021

Package DI Number

00840155411739

Quantity per Package

10

Contains DI Package

00840155411722

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box