o_two CPAP 01CV0217-CS

GUDID 17540195035062

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 adjust

O-Two Medical Technologies Inc

CPAP/BPAP face mask, single-use

• Primary Device ID: 17540195035062
• NIH Device Record Key: ae1ed7ec-3500-4346-a74e-a0f1715f56cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: o_two CPAP
• Version Model Number: 01CV0217
• Catalog Number: 01CV0217-CS
• Company DUNS: 206449154
• Company Name: O-Two Medical Technologies Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-387-3405
• Email: cs@otwo.com

Device Dimensions

• Weight: 0.1 Kilogram

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540195035065 [Primary]
GS1	17540195035062 [Package]; Contains: 07540195035065; Package: Cafrton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112546

FDA Product Code

• BYE: Attachment, Breathing, Positive End Expiratory Pressure

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [o_two CPAP]

• 17540195035147: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
• 17540195035130: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
• 07540195035126: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
• 17540195035116: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
• 17540195035109: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
• 17540195035093: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
• 17540195035086: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
• 17540195035079: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
• 17540195035062: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
• 07540195035058: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
• 17540195035048: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
• 17540195035031: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.
• 17540195035024: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients.