O-Two 02FM5207-CS

GUDID 17540195010335

The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is designed to be positioned over a patient’s nose or mouth to direct oxygen or anesthetic gases or aerosols to the upper airway. The size #3 cuff mask 02FM5203 fits small Adult patients.

O-Two Medical Technologies Inc

Anaesthesia face mask, single-use

• Primary Device ID: 17540195010335
• NIH Device Record Key: 4e7d376b-ae5f-4997-9dbf-05a3eb97ca3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-Two
• Version Model Number: 02FM5207
• Catalog Number: 02FM5207-CS
• Company DUNS: 206449154
• Company Name: O-Two Medical Technologies Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540195010338 [Primary]
GS1	17540195010335 [Package]; Contains: 07540195010338; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• BSJ: Mask, Gas, Anesthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-24
• Device Publish Date: 2019-10-16

On-Brand Devices [O-Two]

• 17540195004518: The Child Ventilation Timer is intended to guide the rescuer to provide ventilation at a rate ap
• 17540195004501: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilation at a rate ap
• 07540195054219: The Multi Patient Unit is intended for delivery of adjustable oxygen therapy flow rates (0-15 L/
• 17540195010359: The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is
• 17540195010342: The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is
• 17540195010335: The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is
• 17540195010328: The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is
• 07540195010314: The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is
• 07540195010307: The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is
• 17540195010151: O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m
• 17540195010144: O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m
• 07540195010130: O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m
• 17540195010120: O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m
• 17540195010113: O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m
• 17540195010106: O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m
• 17540195010038: O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m
• 07540195010024: O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m
• 17540195010014: O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/m
• 07540195071322: The Single-use Adult Nasal Cannula with Tubing is used to deliver supplemental oxygen to an adul
• 07540195071308: The Single-use Adult Nasal Cannula is used to deliver supplemental oxygen to an adult patient i
• 07540195070219: The Single-use Adult Medium Concentration Mask with Tubing is used to provide respiratory therap
• 07540195070202: The Single-use Adult Medium Concentration Mask is used to provide respiratory therapy. It is ach
• 17540195005331: The O-Two single-use electronic ventilator ventilation circuit consists of a single ventilation
• 17540195005218: The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve o
• 17540195005188: The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve o
• 17540195005171: The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve o
• 07540195005129: The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve o
• 07540195086616: Nitrous Oxide Regulator
• 07540195060241: Oxygen Regulator
• 07540195060111: Oxygen Regulator- Pressure
• 17540195035154: O-Two Single-Use CPAP Nebulizer System c/w 6 L/min Flow Adapter, T-Piece, Updraft Nebulizer with
• 07540195050075: FLOW CONTROL 0-25 LPM O2 DISS. The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrat
• 07540195050051: The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice,
• 07540195015036: Supply Hose Assembly
• 07540195015029: Supply Hose Assembly
• 07540195015012: Nitrile Powder Free Gloves