O-Two

Basic Information

• Brand Name: O-Two
• Primary DI: 07540195005129
• Version / Model: 01CV8010
• Catalog Number: 01CV8010-CS
• 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: 2019-05-31
• Public Version: 3
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 04631c55-99aa-4f6b-b79d-5df4f7c6efc0

Device Description

The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve. The 01CV8010 is specifically designed for use on Bag-Valve-Mask resuscitators and ventilators without demand breathing or patient triggered ventilation modes.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	868.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37706	Ventilator breathing circuit, single-use	An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540195005129	GS1
Package	17540195005126	GS1		10	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	80	Gram
Length	40	Inch

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius