AccessGUDID - DEVICE: O-Two (07540195039001)

GUDID

Device Identifier (DI) Information

Brand Name: O-Two
Version or Model: 01AM3000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01AM3000
Company Name: O-Two Medical Technologies Inc

Primary DI Number: 07540195039001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 206449154 *Terms of Use

Device Description: O-Two Guedel Airway is an oropharyngeal airway insert into a patient’s pharynx through the mouth to provide a patent airway. The Air Way Kit 01AM3000 contains eight sizes of air ways: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42424	Oropharyngeal airway, single-use	A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAE	Airway, Oropharyngeal, Anesthesiology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 190 Gram
Length: 7.0 Inch
Width: 4.5 Inch
Height: 2.0 Inch

Device Record Status

Public Device Record Key: 2f16647c-28c2-41f5-816d-8cd9e8b36bb7
Public Version Date: June 10, 2019
Public Version Number: 1
DI Record Publish Date: May 31, 2019