O-Two - O-Two Guedel Airway is an oropharyngeal airway - O-Two Medical Technologies Inc

Duns Number:206449154

Device Description: O-Two Guedel Airway is an oropharyngeal airway insert into a patient’s pharynx through the O-Two Guedel Airway is an oropharyngeal airway insert into a patient’s pharynx through the mouth to provide a patent airway. It provides eight sizes: 40MM, 50MM 60MM, 70MM, 80MM, 90MM, 100MM AND 110MM. The bit block is rigid and identified with color coding. The smooth surface and rounded tip can improve patient comfort. O-Two Guedel Airway is manufactured with 100% Polyethylene (PE) which is latex free and for single use only. The size of 01AM3003 is 60 mm.

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More Product Details

Catalog Number

01AM3003

Brand Name

O-Two

Version/Model Number

01AM3003U

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CAE

Product Code Name

Airway, Oropharyngeal, Anesthesiology

Device Record Status

Public Device Record Key

a90c82db-a989-47b6-a58f-d82895ff17d9

Public Version Date

June 10, 2019

Public Version Number

1

DI Record Publish Date

May 31, 2019

Additional Identifiers

Package DI Number

17540195039039

Quantity per Package

50

Contains DI Package

07540195039032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"O-TWO MEDICAL TECHNOLOGIES INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 32
2 A medical device with a moderate to high risk that requires special controls. 48
U Unclassified 3