Catalog Number

Not Applicable

Brand Name

MedSource Airway Devices

Version/Model Number

MS-23905

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

a4641012-a9c1-46c9-8a0a-ba8d8fdd10c3

Public Version Date

May 26, 2021

Public Version Number

1

DI Record Publish Date

May 18, 2021

Package DI Number

00816703026519

Quantity per Package

10

Contains DI Package

00816703026502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case