O Two Medical Technologies Inc

FDA Filings

This page includes the latest FDA filings for O Two Medical Technologies Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9610861
• FEI Number: 3002807836
• Name: O-TWO MEDICAL TECHNOLOGIES, INC.
• Owner & Operator: O-TWO MEDICAL TECHNOLOGIES, INC.
• Contact Address: 45A Armthorpe Road --; Brampton CA-ON Ontario L6T 5M4 CA
• US Agent:
  • GERALD DOANE
  • TOBIAS SYSTEMS, LLC
  • 716 7750533
  • jdoane@usagent-tobias.com
• Importing Logistics Registration:
  • Importer: B & A Products
  • Address: 700 East Shwntel Smith Blvd ; Muldrow, OK 74948 UNITED STATES
• Importing Logistics Registration:
  • Importer: Bellegrove Medical Supply
  • Address: 8349-154th Ave NE ; Redmond, WA 98052 UNITED STATES
  • Importer Type: Retailer
• Importing Logistics Registration:
  • Importer: Life-Assist Inc.
  • Address: 11277 Sunrise Park Dr. ; Rancho Cordova, CA 95742 UNITED STATES
• Importing Logistics Registration:
  • Importer: Wyle Laboratories
  • Address: 1290 Hercules Drive#120 ; Houston, TX 77058 UNITED STATES
  • Phone: 1 281 2121494
  • FAX: 1 281 2041597
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 45A Armthorpe Road ; Brampton Ontario, L6T 5M4 CA
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 17540195040073 O-Two Medical Technologies Inc	Pro Nox	2023-11-21
GUDID 07540195050075 O-Two Medical Technologies Inc	O-Two	2023-11-15
GUDID 07540195050051 O-Two Medical Technologies Inc	O-Two	2023-11-15
GUDID 07540195015036 O-Two Medical Technologies Inc	O-Two	2023-11-15
GUDID 07540195015029 O-Two Medical Technologies Inc	O-Two	2023-11-15
GUDID 07540195015012 O-Two Medical Technologies Inc	O-Two	2023-11-15
GUDID 17540195035154 O-Two Medical Technologies Inc	O-Two	2023-06-30
GUDID 07540195086616 O-Two Medical Technologies Inc	O-TWO	2023-06-14
GUDID 07540195060241 O-Two Medical Technologies Inc	O-TWO	2023-06-14
GUDID 07540195060111 O-Two Medical Technologies Inc	O-TWO	2023-06-14
GUDID 17540195056029 O-Two Medical Technologies Inc	CPR Bio-Barrier Training Faceshield 01RB5050	2020-04-06
GUDID 17540195055077 O-Two Medical Technologies Inc	Rescue Breather CPR Protective Barrier 01RB2020-RB	2020-04-06
GUDID 17540195055060 O-Two Medical Technologies Inc	Rescue Breather CPR Protective barrier 01RB2020-R	2020-04-06
GUDID 17540195055046 O-Two Medical Technologies Inc	Rescue Breather CPR Protective Barrier 01RB2010-RB	2020-04-06
GUDID 07540195055056 O-Two Medical Technologies Inc	Rescue Breather CPR Protective Barrier 01RB2020-B	2020-04-06
GUDID 07540195055032 O-Two Medical Technologies Inc	Rescue Breather CPR Protective Barrier 01RB2010-R	2020-04-06
GUDID 07540195055025 O-Two Medical Technologies Inc	Rescue Breather CPR Protective Barrier 01RB2010-B	2020-04-06
GUDID 07540195055018 O-Two Medical Technologies Inc	Rescue Breather 01RB1000	2020-04-06
GUDID 17540195005331 O-Two Medical Technologies Inc	O-Two 01CV8030-CS	2019-11-27
GUDID 17540195005218 O-Two Medical Technologies Inc	O-Two 01CV8019-CS	2019-11-27
GUDID 17540195005188 O-Two Medical Technologies Inc	O-Two 01CV8016-CS	2019-11-27
GUDID 17540195005171 O-Two Medical Technologies Inc	O-Two 01CV8015-CS	2019-11-27
GUDID 07540195005129 O-Two Medical Technologies Inc	O-Two 01CV8010-CS	2019-11-27
GUDID 07540195071322 O-Two Medical Technologies Inc	O-Two 02RT1012-CS	2019-11-08
GUDID 07540195071308 O-Two Medical Technologies Inc	O-Two 02RT1010-CS	2019-11-08
GUDID 07540195070219 O-Two Medical Technologies Inc	O-Two 02RT1041-CS	2019-11-08
GUDID 07540195070202 O-Two Medical Technologies Inc	O-Two 02RT1040-CS	2019-11-08
GUDID 17540195010359 O-Two Medical Technologies Inc	O-Two 02FM5210-CS	2019-10-24
GUDID 17540195010342 O-Two Medical Technologies Inc	O-Two 02FM5208-CS	2019-10-24
GUDID 17540195010335 O-Two Medical Technologies Inc	O-Two 02FM5207-CS	2019-10-24
GUDID 17540195010328 O-Two Medical Technologies Inc	O-Two 02FM5206-CS	2019-10-24
GUDID 17540195010151 O-Two Medical Technologies Inc	O-Two 02FM5102-CS	2019-10-24
GUDID 17540195010144 O-Two Medical Technologies Inc	O-Two 02FM5101-CS	2019-10-24
GUDID 17540195010120 O-Two Medical Technologies Inc	O-Two 02FM5099-CS	2019-10-24
GUDID 17540195010113 O-Two Medical Technologies Inc	O-Two 02FM5098-CS	2019-10-24
GUDID 17540195010106 O-Two Medical Technologies Inc	O-Two 02FM5097-CS	2019-10-24
GUDID 17540195010038 O-Two Medical Technologies Inc	O-Two 02FM5001-CS	2019-10-24
GUDID 17540195010014 O-Two Medical Technologies Inc	O-Two 02FM4999-CS	2019-10-24
GUDID 07540195054219 O-Two Medical Technologies Inc	O-Two 01OR6304	2019-10-24
GUDID 07540195010314 O-Two Medical Technologies Inc	O-Two 02FM5205-CS	2019-10-24
GUDID 07540195010307 O-Two Medical Technologies Inc	O-Two 02FM5203-CS	2019-10-24
GUDID 07540195010130 O-Two Medical Technologies Inc	O-Two 02FM5100-CS	2019-10-24
GUDID 07540195010024 O-Two Medical Technologies Inc	O-Two 02FN5000-CS	2019-10-24
GUDID 17540195004518 O-Two Medical Technologies Inc	O-Two 01BM1500-CS	2019-05-13
GUDID 17540195004501 O-Two Medical Technologies Inc	O-Two 01BM1000-CS	2019-05-13
GUDID 07540195040045 O-Two Medical Technologies Inc	Equinox Relieve 01EQ1000F	2019-05-13
GUDID 17540195056517 O-Two Medical Technologies Inc	Rescue Breather 01PV1503W-CS	2019-05-10
GUDID 17540195056500 O-Two Medical Technologies Inc	Rescue Breather 01PV1500W-CS	2019-05-10
GUDID 17540195000497 O-Two Medical Technologies Inc	SMART BAG MO 01BM3211-MO-TL-CS	2019-05-10
GUDID 17540195000480 O-Two Medical Technologies Inc	SMART BAG MO 01BM3211-MOTP-CS	2019-05-10
GUDID 17540195000237 O-Two Medical Technologies Inc	SMART BAG MO 01BM3201-MOTP-CS	2019-05-10
GUDID 07540195025097 O-Two Medical Technologies Inc	CAREvent DRA 01CV3400	2019-05-10
GUDID 07540195040052 O-Two Medical Technologies Inc	Equinox Advantage 01EQ2000	2018-11-30
GUDID 07540195040014 O-Two Medical Technologies Inc	Equinox Relieve 01EQ1000	2018-11-26
PMN K173205 | BZR O-TWO MEDICAL TECHNOLOGIES, INC.	Equinox Advantage	2018-10-25
PMN K173205 O-Two Medical Technologies Inc.	Equinox Advantage	2018-08-29
GUDID 07540195053038 O-Two Medical Technologies Inc	STATVAC II Oxygen powered Aspirator 01AS9502	2018-08-23
GUDID 07540195053007 O-Two Medical Technologies Inc	STATVAC II Oxygen powered Aspirator 01AS9500	2018-08-23
GUDID 17540195037004 O-Two Medical Technologies Inc	O-Two Disposable Pressure manometer 0-20cmH2O 01CV8066	2018-07-06
GUDID 17540195035147 O-Two Medical Technologies Inc	o_two CPAP 01CV0229-CS	2018-07-06
GUDID 17540195035130 O-Two Medical Technologies Inc	o_two CPAP 01CV0228-CS	2018-07-06
GUDID 17540195035116 O-Two Medical Technologies Inc	o_two CPAP 01CV0223-CS	2018-07-06
GUDID 17540195035109 O-Two Medical Technologies Inc	o_two CPAP 01CV0222-CS	2018-07-06
GUDID 17540195035093 O-Two Medical Technologies Inc	o_two CPAP 01CV0221-CS	2018-07-06
GUDID 17540195035086 O-Two Medical Technologies Inc	o_two CPAP 01CV0219-CS	2018-07-06
GUDID 17540195035079 O-Two Medical Technologies Inc	o_two CPAP 01CV0218-CS	2018-07-06
GUDID 17540195035062 O-Two Medical Technologies Inc	o_two CPAP 01CV0217-CS	2018-07-06
GUDID 17540195035031 O-Two Medical Technologies Inc	o_two CPAP 01CV0211-CS	2018-07-06
GUDID 17540195035024 O-Two Medical Technologies Inc	o_two CPAP 01CV0210-CS	2018-07-06
GUDID 17540195000220 O-Two Medical Technologies Inc	SMART BAG MO 01BM3201-MO-TL-CS	2018-07-06
GUDID 17540195000206 O-Two Medical Technologies Inc	SMART BAG MO 01BM3200-MO-TL-CS	2018-07-06
GUDID 17540195000145 O-Two Medical Technologies Inc	SMART BAG MO 01`BM3211-MO-CS	2018-07-06
GUDID 17540195000107 O-Two Medical Technologies Inc	SMART BAG MO 01BM3201-MO-CS	2018-07-06
GUDID 17540195000084 O-Two Medical Technologies Inc	SMART BAG MO 01BM3200-MO-CS	2018-07-06
GUDID 07540195054004 O-Two Medical Technologies Inc	Fingertip Pulse Oximeter 01MN1000	2018-07-06
GUDID 07540195036000 O-Two Medical Technologies Inc	CARevent CPAP 01CV0200	2018-07-06
GUDID 07540195035126 O-Two Medical Technologies Inc	o_two CPAP 01CV0227-CS	2018-07-06
GUDID 07540195035058 O-Two Medical Technologies Inc	o_two CPAP 01CV0213-CS	2018-07-06
GUDID 07540195033054 O-Two Medical Technologies Inc	o_two e500 01EVE500	2018-07-06
GUDID 07540195033030 O-Two Medical Technologies Inc	o_two e600 01EVE600	2018-07-06
GUDID 07540195033009 O-Two Medical Technologies Inc	o_two e700 01EVE700	2018-07-06
GUDID 07540195030183 O-Two Medical Technologies Inc	CAREvent MRI 01CV7000	2018-07-06
GUDID 07540195025332 O-Two Medical Technologies Inc	CAREvent PAR 01CV0100	2018-07-06
GUDID 07540195025325 O-Two Medical Technologies Inc	CAFREvent ALS+ CPAP 01CV4000-CPAP	2018-07-06
GUDID 07540195025295 O-Two Medical Technologies Inc	CAREvent ALS+ 01CV4000	2018-07-06
GUDID 07540195025202 O-Two Medical Technologies Inc	CAREvent CA 01CV3000-CA	2018-07-06
GUDID 07540195025165 O-Two Medical Technologies Inc	CAREvent ALS 01CV3000	2018-07-06
GUDID 07540195025127 O-Two Medical Technologies Inc	CAREvent ALS 01CV3112	2018-07-06
GUDID 07540195025110 O-Two Medical Technologies Inc	CAREvent ALS 01CV3100	2018-07-06
GUDID 07540195025042 O-Two Medical Technologies Inc	CAREvent EMT 01CV0500	2018-07-06
GUDID 07540195020115 O-Two Medical Technologies Inc	Oxygen Demand Valve 01DV3000	2018-07-06
GUDID 07540195020016 O-Two Medical Technologies Inc	O-wo Demand Valve 01DV2000	2018-07-06
GUDID 07540195000186 O-Two Medical Technologies Inc	SMART BAG MO 01BM3410-MO	2018-07-06
GUDID 07540195000162 O-Two Medical Technologies Inc	SAMRT BAG MO 01BM3400-MO	2018-07-06
GUDID 07540195000124 O-Two Medical Technologies Inc	SMART BAG MO 01BM3210-MO	2018-07-06
GUDID 07540195000063 O-Two Medical Technologies Inc	SAMRT BAG MO 01BM3110-MO	2018-07-06
GUDID 07540195000025 O-Two Medical Technologies Inc	SMART BAG MO 01BM3100-MO	2018-07-06
GUDID 17540195000275 O-Two Medical Technologies Inc	EASY GRIP 01BM3511-CS	2018-03-29
GUDID 17540195000268 O-Two Medical Technologies Inc	EASY Grip 01BM3510-CS	2018-03-29
GUDID 17540195000251 O-Two Medical Technologies Inc	EASY GRIP 01BM3501-CS	2018-03-29
GUDID 07540195000285 O-Two Medical Technologies Inc	EASY Grip 01BM3520-CS	2018-03-29
GUDID 07540195000247 O-Two Medical Technologies Inc	EASY GRIP 01BM3500-CS	2018-03-29
PMN K141595 O-TWO MEDICAL TECHNOLOGIES, INC.	O-TWO E700,O-TWO E600,O-TWO E500	2015-03-16
PMN K141595 | BTL O-TWO MEDICAL TECHNOLOGIES, INC.	o_two e700, e600 and e500	2015-03-16
PMN K121770 | CAF O-TWO MEDICAL TECHNOLOGIES, INC.	Nebulizer Kit	2014-05-05
PMN K121770 | CAF O-TWO MEDICAL TECHNOLOGIES, INC.	Jet Nebulizer	2014-05-05
PMN K102377 | CAP O-TWO MEDICAL TECHNOLOGIES, INC.	Disposable Pressure Manometer	2013-07-09
JBS O-TWO MEDICAL TECHNOLOGIES, INC.	CPR Ventilation Timer	2012-08-17
BSJ O-TWO MEDICAL TECHNOLOGIES, INC.	O-Two Facemask	2012-08-10
PMN K113687 | BZR O-TWO MEDICAL TECHNOLOGIES, INC.	PRO-NOX	2012-05-28
PMN K113687 | BZR O-TWO MEDICAL TECHNOLOGIES, INC.	Equinox Relieve	2012-05-28
PMN K112546 | BYE O-TWO MEDICAL TECHNOLOGIES, INC.	o_two CPAP System	2012-05-28
PMN K113687 O-TWO MEDICAL TECHNOLOGIES, INC.	EQUINOX RELIEVE	2012-04-30
PMN K112546 O-TWO MEDICAL TECHNOLOGIES, INC.	O_TWO CPAP SYSTEM	2011-12-27
PMN K093862 | BYE O-TWO MEDICAL TECHNOLOGIES, INC.	CAREvent Handheld CPAP System	2010-05-07
PMN K093862 | BTL O-TWO MEDICAL TECHNOLOGIES, INC.	CAREvent Handheld CPAP System	2010-05-07
PMN K093862 O-TWO MEDICAL TECHNOLOGIES, INC.	CAREVENT HANDHELD CPAP SYSTEM	2010-05-06
BTA O-TWO MEDICAL TECHNOLOGIES, INC.	Statvac II Oxygen Powered Aspirator	2009-12-18
PMN K081330 | BTL O-TWO MEDICAL TECHNOLOGIES, INC.	CAREvent PAR	2009-07-10
PMN K070371 | DQA O-TWO MEDICAL TECHNOLOGIES, INC.	Finger Tip Pulse Oximeter	2009-07-09
PMN K081330 O-TWO MEDICAL TECHNOLOGIES, INC.	CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)	2009-03-06
PMN K991195 | BTL O-TWO MEDICAL TECHNOLOGIES, INC.	CAREvent BLS, BLS+, ALS, ALS+, ATV	2007-10-22
PMN K983705 | BTL O-TWO MEDICAL TECHNOLOGIES, INC.	CAREvent EMT	2007-10-22
PMN K960995 | CBP O-TWO MEDICAL TECHNOLOGIES, INC.	CPR Bio-Barrier Facesheild	2007-10-22
PMN K940927 | LYM O-TWO MEDICAL TECHNOLOGIES, INC.	Rescue Breather	2007-10-22
PMN K932170 | BTL O-TWO MEDICAL TECHNOLOGIES, INC.	Genesis II A/C, A/O and IDLH	2007-10-22
PMN K922810 | BTM O-TWO MEDICAL TECHNOLOGIES, INC.	O-Two Demand Valve	2007-10-22
PMN K051889 | BTL O-TWO MEDICAL TECHNOLOGIES, INC.	CAREvent CA & CAREvent DRA	2007-10-22
PMN K051469 | BTL O-TWO MEDICAL TECHNOLOGIES, INC.	CAREvent ATV+ & CAREvent MRI	2007-10-22
PMN K021328 | BTM O-TWO MEDICAL TECHNOLOGIES, INC.	SMART BAG-MO	2007-10-22
PMN K002846 | BTM O-TWO MEDICAL TECHNOLOGIES, INC.	Easy Grip	2007-10-22
PMN K040841 | LZA O-TWO MEDICAL TECHNOLOGIES, INC.	NITRILE POWER FREE EXAM GLOVES	2007-04-17
PMN K051469 O-TWO MEDICAL TECHNOLOGIES, INC.	CAREVENT ATV+ AND CAREVENT MRI	2005-09-28
PMN K051889 O-TWO MEDICAL TECHNOLOGIES, INC.	CAREVENT CA AND DRA	2005-08-30
CAI O-TWO MEDICAL TECHNOLOGIES, INC.	O-TWO REUSABLE VENTILATION CIRCUIT	2005-06-20
CAI O-TWO MEDICAL TECHNOLOGIES, INC.	O-TWO DISPOSABLE VENTILATION CIRCUIT	2005-06-20
CAE O-TWO MEDICAL TECHNOLOGIES, INC.	GUEDEL AIRWAY	2005-06-20
CAE O-TWO MEDICAL TECHNOLOGIES, INC.	GUEDEL AIRWAY KIT	2005-06-20
CAN O-TWO MEDICAL TECHNOLOGIES, INC.	Pressure Regulators for Use with Medical Gases	2003-08-05
CAN O-TWO MEDICAL TECHNOLOGIES, INC.	MULTI-PATIENT UNIT	2003-08-05
CAT O-TWO MEDICAL TECHNOLOGIES, INC.	CANNULA NASAL	2003-07-11
CAT O-TWO MEDICAL TECHNOLOGIES, INC.	CANNULA NASAL w/TUBING	2003-07-11
BYX O-TWO MEDICAL TECHNOLOGIES, INC.	SURE FLOW TUBING	2003-07-11
BYX O-TWO MEDICAL TECHNOLOGIES, INC.	CORRUGATED HOSE	2003-07-11
BYG O-TWO MEDICAL TECHNOLOGIES, INC.	MEDIUM CONCENTRATION MASK	2003-07-11
BYG O-TWO MEDICAL TECHNOLOGIES, INC.	AEROSOL MASK	2003-07-11
KGB O-TWO MEDICAL TECHNOLOGIES, INC.	UNIVERSAL POCKET VENTILATOR	1995-09-26
KGB O-TWO MEDICAL TECHNOLOGIES, INC.	MASK, NON-REBREATHING	1995-09-26
CCN O-TWO MEDICAL TECHNOLOGIES, INC.	Therapy Flow Control	1980-01-21
CCN O-TWO MEDICAL TECHNOLOGIES, INC.	Fixed Flow Control	1980-01-21

Related Finance Registrations

NCAGE Code	38186	O-TWO MEDICAL TECHNOLOGIES INC
CAGE Code	38186	O-TWO MEDICAL TECHNOLOGIES INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091765992	Kaohsiung,China (Taiwan) -> Tacoma, Washington	MEDICAL ACCESSORIES HS CODE 902000 903300 . . . .	912 CTN
2020031635282	Kaohsiung,China (Taiwan) -> Tacoma, Washington	MEDICAL APPLIANCES ORDER NO.PO-02950+PO-02895 P.I. NO. H1-190410B+H1-190317G MEDICAL APPLIANCES THE SAME THE SAME THE SAME	720 CTN
2019072645159	Kaohsiung,China (Taiwan) -> Seattle, Washington	MEDICAL APPLIANCES	1980 CTN
2019072645159	Kaohsiung,China (Taiwan) -> Seattle, Washington	MEDICAL APPLIANCES ORDER NO.PO-02950 P.I. NO. H1-190410A MEDICAL APPLIANCES . . @@FAX +1 905 709-3338	1980 CTN
2018083027853	Port Natal,South Africa -> New York/Newark Area, Newark, New Jersey	RESCUE BREATHER	3 PLT
2018060241515	Kaohsiung,China (Taiwan) -> Tacoma, Washington	MEDICAL APPLIANCES HS 902000 ORDER NO.PO-01935 + PO-01667 P.I. NO. H1-180311A + H1-171112D MEDICAL APPLIANCES H.S. CODE 9020.00 THE SAME THE SAME	1156 CTN
2018042621212	Kaohsiung,China (Taiwan) -> Tacoma, Washington	MEDICAL APPLIANCES	611 CTN
2018030638525	Kaohsiung,China (Taiwan) -> Tacoma, Washington	MEDICAL APPLIANCES	2071 CTN
2018030638525	Kaohsiung,China (Taiwan) -> Tacoma, Washington	MEDICAL APPLIANCES	2071 CTN
2018030638643	Kaohsiung,China (Taiwan) -> Tacoma, Washington	MEDICAL APPLIANCES	2071 CTN
2018030638643	Kaohsiung,China (Taiwan) -> Tacoma, Washington	MEDICAL APPLIANCES	2071 CTN