Vortex oxygen face mask

Definition
A non-sterile, form-shaped, fenestrated device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. It incorporates a pin/diffuser intended to create vortices of high-concentration O2 directed to the mouth and nose to provide the full range of FiO2 (fraction of inspired oxygen) required for oxygen therapy. The fenestration designed to prevent positive pressure build-up and rebreathing, also allows for easier communication/feeding. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer) is not included. This is a single-use device.
GUDID devices
52
Last updated
2025-03-17 11:40:57

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
30889483596122AirLife™Sunmed Group Holdings, LLCAM-10002025-03-07
30889483596139AirLife™Sunmed Group Holdings, LLCAM-11002025-03-07
30889483596146AirLife™Sunmed Group Holdings, LLCAM-12002025-03-07
00620974003519Oxy2Mask™Southmedic IncorporatedOK-1125-142023-02-28
00620974003526Oxy2Mask™Southmedic IncorporatedOM-1125-142023-02-28
00620974003533Oxy2Mask™Southmedic IncorporatedOP-1125-142023-02-28
00620974003540Oxy2Mask™Southmedic IncorporatedOM-1425-82023-02-28
00620974003557Oxy2Mask™Southmedic IncorporatedOP-1425-82023-02-28
00620974003571OxyMulti-Mask™Southmedic IncorporatedOKHH-1025-8S2023-02-28
00620974003588OxyMulti-Mask™Southmedic IncorporatedOHH-1025-8S2023-02-28
00620974003595OxyMulti-Mask™Southmedic IncorporatedOPHH-1025-8S2023-02-28
00620974003236OxyMask™ IISouthmedic IncorporatedOM-1125-82022-06-06
00620974003243OxyMask™ IISouthmedic IncorporatedOP-1125-82022-06-06
00620974003250OxyMask™ IISouthmedic IncorporatedOK-1125-82022-06-06
00620974003267OxyMask™ IISouthmedic IncorporatedOT-1025-82022-06-06
00620974003274OxyMask™ IISouthmedic IncorporatedOM-7025-82022-06-06
00620974003281OxyMask™ IISouthmedic IncorporatedOP-7025-82022-06-06
00620974003298OxyMask™ IISouthmedic IncorporatedOK-7025-82022-06-06
00620974003304OxyMask™ IISouthmedic IncorporatedOT-7025-82022-06-06
10620974000584OxyMulti-Mask™Southmedic IncorporatedOPHH-1425-82016-09-01
00620974000020OxyArm™Southmedic IncorporatedOA-DA-10252020-12-18
00620974000044OxyArm™Southmedic IncorporatedOA-DA-30252020-12-18
00620974000051OxyArm™Southmedic IncorporatedOA-HB-11252020-12-18
00620974000075OxyArm™Southmedic IncorporatedOA-PLUS-1125-82020-12-18
00620974000099OxyArm™Southmedic IncorporatedOA-PLUS-3125-82020-12-18
00620974000150OxyKid™Southmedic IncorporatedOK-1125-82020-12-18
00620974000167OxyKid™Southmedic IncorporatedOK-1125-142020-12-18
00620974000204OxyKid™Southmedic IncorporatedOK-7025-82020-12-18
00620974000242OxyMask™Southmedic IncorporatedOM-1125-82020-12-18
00620974000259OxyMask™Southmedic IncorporatedOM-1125-142020-12-18
00620974000266OxyMask™Southmedic IncorporatedOM-1425-82020-12-18
00620974000334OxyMask™Southmedic IncorporatedOM-7025-82020-12-18
00620974000372OxyPlus™Southmedic IncorporatedOP-1125-82020-12-18
00620974000389OxyPlus™Southmedic IncorporatedOP-1125-142020-12-18
00620974000396OxyPlus™Southmedic IncorporatedOP-1425-82020-12-18
00620974000457OxyPlus™Southmedic IncorporatedOP-7025-82020-12-18
00620974000495OxyTyke™Southmedic IncorporatedOT-1025-82020-12-18
00620974000501OxyTyke™Southmedic IncorporatedOT-7025-82020-12-18
00620974000624OxyTrach™Southmedic IncorporatedOAT-10252020-12-18
00620974002123OxyTrach™Southmedic IncorporatedOAT-1025-CS2020-12-18
10620974000225OxyKid™Southmedic IncorporatedOKN-4025-82016-09-01
10620974000478OxyMask™Southmedic IncorporatedOPN-10252016-09-01
10620974000485OxyMask™Southmedic IncorporatedOPN-4025-82016-09-01
10620974000522OxyTyke™Southmedic IncorporatedOTN-4025-82016-09-01
10620974000546OxyMulti-Mask™Southmedic IncorporatedOHH-1425-82016-09-01
10620974000638NASouthmedic IncorporatedOAT-4025-82016-09-01
10620974001369OxyMask™Southmedic IncorporatedOKMK-4025-82016-09-01
10620974001567OxyMulti Kid Ultra™Southmedic IncorporatedOKHH-1425-82016-09-01
00620974002727OxyMask™ IISouthmedic IncorporatedOT2-1025-82020-10-02
00620974002734OxyMask™ IISouthmedic IncorporatedOK2-1125-82020-10-02
00620974002741OxyMask™ IISouthmedic IncorporatedOM2-1125-82020-10-02
00620974002758OxyMask™ IISouthmedic IncorporatedOP2-1125-82020-10-02