Catalog Number

-

Brand Name

Guedel Airways (color coded)

Version/Model Number

10-81670

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

bc1759c4-0d29-45db-9291-3fa43b4c633c

Public Version Date

November 09, 2020

Public Version Number

1

DI Record Publish Date

October 31, 2020

Package DI Number

30641043816701

Quantity per Package

10

Contains DI Package

10641043816707

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-