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 ID17540195010038
NIH Device Record Key79b1d5c8-1cbd-490f-92cf-a5dd0eae3da1
Commercial Distribution StatusIn Commercial Distribution
Brand NameO-Two
Version Model Number02FM5001
Catalog Number02FM5001-CS
Company DUNS206449154
Company NameO-Two Medical Technologies Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-387-3405
Emailcs@otwo.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195010031 [Primary]
GS117540195010038 [Package]
Contains: 07540195010031
Package: [12 Units]
In Commercial Distribution

FDA Product Code

BSJMask, Gas, Anesthetic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-24
Device Publish Date2019-10-16

On-Brand Devices [O-Two]

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

Trademark Results [O-Two]

Mark Image

Registration | Serial
Company
Trademark
Application Date
O-TWO
O-TWO
75550677 not registered Dead/Abandoned
O-Two Systems International Inc.
1998-09-10
O-TWO
O-TWO
73723259 1525468 Dead/Cancelled
O-TWO SYSTEMS INTERNATIONAL INC.
1988-04-08

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