Catalog Number

Not Applicable

Brand Name

MedSource Airways Devices

Version/Model Number

MS-23818

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

ba71c5c3-2501-4fb6-8155-a9d4169dac90

Public Version Date

May 25, 2021

Public Version Number

1

DI Record Publish Date

May 17, 2021

Package DI Number

00816703026359

Quantity per Package

50

Contains DI Package

00816703026342

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case