O-Two 02FM5001-CS

GUDID 17540195010038

O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear PVC facemask is ideal for use where disinfection after use is normally undertaken by cold chemical sterilant.The Large mask 02FM5001 fits adult patients.

O-Two Medical Technologies Inc

Anaesthesia face mask, reusable

• Primary Device ID: 17540195010038
• NIH Device Record Key: 79b1d5c8-1cbd-490f-92cf-a5dd0eae3da1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-Two
• Version Model Number: 02FM5001
• Catalog Number: 02FM5001-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: false
• 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	07540195010031 [Primary]
GS1	17540195010038 [Package]; Contains: 07540195010031; 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