FDA.reportPublic FDA data

O-Two

Primary DI
07540195054219
Brand
O-Two
Company
O-Two Medical Technologies Inc
Model
01OR6304
Catalog number
01OR6304
Device description
The Multi Patient Unit is intended for delivery of adjustable oxygen therapy flow rates (0-15 L/min) to a maximum of six patients via oxygen therapy masks. It also has a self-sealing outlet for connection of an additional respiratory therapy or ventilation device.The Multi Patient Unit is packed with 25’ Oxygen supply hose, Medium concentration masks and Oxygen tubing.
Published
2019-10-16
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
CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAXFlowmeter, Tube, Thorpe, Back-Pressure CompensatedAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540195054219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540195054219075401950542197540195054219

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0.95Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-387-3405cs@otwo.com

Regulatory Flags#

DUNS number
206449154
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
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
07540195050051O-Two 01FCO115D2023-11-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08592346652194Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
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08592346652217Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346652224Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692329Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692404Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692442Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692466Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692503Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346696914Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346705302Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346732926Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782013Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782020Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782075Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782655Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782723Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782730Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346815858Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893153Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893160Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893177Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893184Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893191Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893207Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346905603Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346905665Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346997752Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346997769Amvex FlowmeterGCE, s.r.o.CAX2026-07-07