Catalog Number

-

Brand Name

n.a.

Version/Model Number

40-26-009-1

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

d298944e-1d98-4a84-9671-e3d07098c7f5

Public Version Date

September 03, 2020

Public Version Number

1

DI Record Publish Date

August 26, 2020

Package DI Number

14250105601944

Quantity per Package

30

Contains DI Package

04250105601947

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-