Catalog Number

Not Applicable

Brand Name

MedSource Airway Devices

Version/Model Number

MS-23954

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

BTQ

Product Code Name

Airway, Nasopharyngeal

Public Device Record Key

4161d59a-03c9-4f94-93a6-c2bec9c7ed01

Public Version Date

May 27, 2021

Public Version Number

1

DI Record Publish Date

May 19, 2021

Package DI Number

00816703026618

Quantity per Package

10

Contains DI Package

00816703026601

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box