O-Two 02FM5203-CS
GUDID 07540195010307
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 #2 cuff mask 02FM5203 fits Child patients.
O-Two Medical Technologies Inc
Anaesthesia face mask, single-use| Primary Device ID | 07540195010307 |
| NIH Device Record Key | c4826a3a-e3d0-42a3-a186-f7c27be333b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | O-Two |
| Version Model Number | 02FM5203 |
| Catalog Number | 02FM5203-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 |
| 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 | 07540195010307 [Primary] |
| GS1 | 17540195010304 [Package] 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 |
Trademark Results [O-Two]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 O-TWO 75550677 not registered Dead/Abandoned |
O-Two Systems International Inc. 1998-09-10 |
 O-TWO 73723259 1525468 Dead/Cancelled |
O-TWO SYSTEMS INTERNATIONAL INC. 1988-04-08 |
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