Catalog Number

-

Brand Name

I-GEL O2 RESUS PACK - SIZE 5

Version/Model Number

8705030

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

Yes

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

f64715a9-6a19-4e9b-a864-eb66e185896c

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 20, 2021

Package DI Number

05030267104550

Quantity per Package

6

Contains DI Package

05030267103430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-