o_two CPAP

Basic Information

• Brand Name: o_two CPAP
• Primary DI: 07540195035034
• Version / Model: 01CV0211
• Catalog Number: 01CV0211-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: 2015-10-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: bb94fb60-299e-4254-9655-545859a53fc7

Device Description

The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients. The adjustment of the CPAP level is achieved by adjusting the output flow from oxygen therapy regulator or wall outlet. The setting selections noted on the device provide an accurate constant airway pressure at each flow setting

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	868.5965	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57813	CPAP/BPAP face mask, single-use	A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17540195035031	GS1	Carton	10	In Commercial Distribution
Primary	07540195035034	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K112546	000

Device Sizes

Type	Value	Unit	Text
Weight	0.1	Kilogram

Storage Conditions

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