Catalog Number

-

Brand Name

NA

Version/Model Number

FlexiView #5

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

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

dcf86f5b-ee29-4da3-b334-f3622e078d65

Public Version Date

August 31, 2022

Public Version Number

1

DI Record Publish Date

August 23, 2022

Package DI Number

16974599110437

Quantity per Package

10

Contains DI Package

06974599110430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-