Catalog Number

-

Brand Name

Guedel Airways

Version/Model Number

7-3601

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

b8e0d48f-67de-43ee-b52d-0bbf9bf5afe4

Public Version Date

August 08, 2019

Public Version Number

1

DI Record Publish Date

July 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-