FDA.reportPublic FDA data

O-Two

Primary DI
07540195050051
Brand
O-Two
Company
O-Two Medical Technologies Inc
Model
01FCO115D
Device description
The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice, non-gravity sensitive flow controller. T
Published
2023-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCNFlowmeter, Nonback-Pressure Compensated, Bourdon GaugeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540195050051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540195050051075401950500517540195050051

GMDN Terms#

Term, Definition table
TermDefinition
Medical gas flowmeter, dial-typeA device intended to regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It has a pre-calibrated adjustable flow selection dial intended to control the gas flow rate; it is not intended to provide flow rate measurements. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(905) 792-6896resuscitation@otwo.com

Regulatory Flags#

DUNS number
206449154
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540195015029O-Two 17MP13292023-11-07
07540195015036O-Two 17MP11302023-11-07
07540195020252O Two 01DV2000-FER2024-04-29
07540195020269O Two 01DV2000-FER2024-04-29
17540195040073Pro NoxCMI-0100-PNX 2023-11-13
07540195015012O-Two 08GL1042U2023-11-07
07540195050075O-Two 01FCO125D2023-11-07
07540195035157O-Two 01CV02202023-06-22
17540195035154O-Two 01CV02202023-06-22
07540195060111O-TWO 01RO01O10-B2023-06-06
07540195060241O-TWO 01RO01O23-B2023-06-06
07540195086616O-TWO 01RN09N10-B2023-06-06
07540195005174O-Two01CV801501CV8015-CS2019-05-31
07540195005181O-Two01CV801601CV8016-CS2019-05-31
07540195005211O-Two01CV801901CV8019-CS2019-05-31
07540195005334O-Two01CV803001CV8030-CS2019-05-31
07540195005129O-Two01CV801001CV8010-CS2019-05-31
07540195071308O-Two02RT101002RT1010-CS2019-10-31
07540195071322O-Two02RT101202RT1012-CS2019-10-31
07540195054004Fingertip Pulse Oximeter01MN100001MN10002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00026072022429EMAllied Medical, LLCCCN2024-10-11
00026072022436EMAllied Medical, LLCCCN2024-10-11
06977645350170SINYADanyang Xinya Valve Co., Ltd.CCN2024-08-06
16977645350177SINYADanyang Xinya Valve Co., Ltd.CCN2024-08-06
00026072022399EMAllied Medical, LLCCCN2024-05-28
00026072022405EMAllied Medical, LLCCCN2024-05-28
00026072022412EMAllied Medical, LLCCCN2024-05-28
07540200000460Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000477Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000484Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000491Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000545Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540200000552Amico Patient Care CorporationAmico Patient Care CorporationCCN2023-11-14
07540195050075O-Two O-Two Medical Technologies IncCCN2023-11-07
00628101502768FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502775FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502782FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502799FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502805FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502812FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502829FLOWMETER, DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502690Flowmeter DialOHIO MEDICAL, LLCCCN2020-09-04
00628101502706FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502713FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502720FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502737FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502744FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04
00628101502751FLOWMETER DIALOHIO MEDICAL, LLCCCN2020-09-04