O-Two

Basic Information

• Brand Name: O-Two
• Primary DI: 07540195071322
• Version / Model: 02RT1012
• Catalog Number: 02RT1012-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: 2019-10-31
• Public Version: 2
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: 2731d45c-ed37-4ec9-9390-852f72779161

Device Description

The Single-use Adult Nasal Cannula with Tubing is used to deliver supplemental oxygen to an adult patient in need of respiratory help. This device consists of a nose prong, a thin tube, a quick disconnector and oxygen tubing.

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
CAT	Cannula, Nasal, Oxygen	Anesthesiology	868.5340	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35201	Nasal oxygen cannula, basic	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540195071322	GS1
Package	17540195071329	GS1		50	In Commercial Distribution

Customer Contacts

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

Storage Conditions

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