O-Two

Basic Information

• Brand Name: O-Two
• Primary DI: 07540195054219
• Version / Model: 01OR6304
• Catalog Number: 01OR6304
• Company Name: O-Two Medical Technologies Inc
• Labeler DUNS: 206449154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-16
• Public Version: 1
• Public Version Date: 2019-10-24
• Public Version Status: New
• Public Device Record Key: 2a076ee9-704c-4f04-b27a-a1f2ad19d781

Device Description

The Multi Patient Unit is intended for delivery of adjustable oxygen therapy flow rates (0-15 L/min) to a maximum of six patients via oxygen therapy masks. It also has a self-sealing outlet for connection of an additional respiratory therapy or ventilation device.The Multi Patient Unit is packed with 25’ Oxygen supply hose, Medium concentration masks and Oxygen tubing.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	868.2340	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61366	Medical gas flowmeter, dial-type	A device intended to regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It has a pre-calibrated adjustable flow selection dial intended to control the gas flow rate; it is not intended to provide flow rate measurements. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540195054219	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	0.95	Kilogram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius