FDA.reportPublic FDA data

Resp-O2 Venturi Select A Vent Elongated Adult Mask w/ 6 Dilutors

Primary DI
00840117310797
Brand
Resp-O2 Venturi Select A Vent Elongated Adult Mask w/ 6 Dilutors
Company
Dynarex Corporation
Model
33070
Device description
"7' (2.1m) Crush Resistant Tubing, Standard Connector. Components: 1 - Adult Mask, 1 - 6"" Flex Tube, 1 - Humidity Connector, 1 - 7' Oxygen Tubing, 6 - Diluters ( Blue 24%, Yellow 28%, White 31%, Green 35%, Pink 40%, Orange 50% ) "
Published
2021-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYFMask, Oxygen, Low Concentration, Venturi

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYFMask, Oxygen, Low Concentration, VenturiAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117310803PackageGS150In Commercial Distribution
00840117310797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117310803008401173108038401173108030840117310803
00840117310797008401173107978401173107970840117310797

GMDN Terms#

Term, Definition table
TermDefinition
Venturi oxygen face maskA flexible, form-shaped 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. The device typically includes a variety of exchangeable inserts (the venturi) that allow air entrainment in controlled amounts to provide the desired O2 concentration. It is connected to an O2 source with tubing and includes headstraps for stabilization. Adaptors are typically included for connection to a humidification source. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117320925Resp-O2 Incentive Spirometer. Tri-Flow Chamber361022021-04-22
00840117324510Dynarex Bari + Max Bariatric HD Composit Swing Down Rail129542022-11-01
00616784295015Metal Swing Rail129502022-05-09
00616784295114Composite Swing Rail129512022-05-09
00616784295213Q Assist Bar129522022-05-09
00616784295312Pivot Assist Bar129532022-05-09
00616784296012Universal Rotating Assist Bar129602022-05-09
00616784296111Universal Pivot Assist Bar129612022-05-09
00840117303478Expansion Kit for D300129142022-05-09
00840117348578Standard Sling Seat/Back Sling, Mesh10750MS2019-12-30
00840117348592Standard Sling Seat/Back Sling, Canvas10750CN2019-12-30
00840117348615Standard Sling Seat/Back Sling, Mesh With Commode Opening10751MS2019-12-30
00840117348639Standard Sling Seat/Back Sling, Canvas With Commode Opening10751CN2019-12-30
00840117348653Standard Seat/Back Sling - Canvas, Adult Large107522019-12-30
00616784075419Replacement Straps For Standard Slings107542021-04-19
00840117324527Bariatric HD Long-Term Care Bed, DB600, 5 Function Low Bed, Expands to 54"120142022-11-21
00840117302891Long-Term Care Bed, D100120012021-02-03
00840117302907Long Term Care Bed, D200120022021-02-03
00840117302914Long-Term Care Bed D300, 5 Function Low Bed120032021-02-03
00840117302945Bariatric HD Long-Term Care Bed, DB300, 5 Function Low Bed120132021-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851232007202OXYJET VENTURI DEVICE WITH TUBINGD R BURTON HEALTHCARE, LLCBYF2026-04-28
10889483569436AirLife™AIRLIFEBYF2025-02-19
30889483569430AirLife™Sunmed Group Holdings, LLCBYF2025-02-19
00848530099114Aerosol & NebsSUNSET HEALTHCARE SOLUTIONS, INC.BYF2024-08-07
00848530089955Tracheostomy Oxygen MaskcSUNSET HEALTHCARE SOLUTIONS, INC.BYF2024-06-27
00848530096250Aerosol & NebsSUNSET HEALTHCARE SOLUTIONS, INC.BYF2024-06-15
00848530092931CPAP KitSUNSET HEALTHCARE SOLUTIONS, INC.BYF2024-06-08
00848530092948CPAP KitSUNSET HEALTHCARE SOLUTIONS, INC.BYF2024-06-08
00848530092955CPAP KitSUNSET HEALTHCARE SOLUTIONS, INC.BYF2024-06-08
00848530092962CPAP KitSUNSET HEALTHCARE SOLUTIONS, INC.BYF2024-06-08
00848530092979CPAP KitSUNSET HEALTHCARE SOLUTIONS, INC.BYF2024-06-08
00848530092986CPAP KitSUNSET HEALTHCARE SOLUTIONS, INC.BYF2024-06-08
00848530092993CPAP KitSUNSET HEALTHCARE SOLUTIONS, INC.BYF2024-06-08
00848530093006CPAP KitSUNSET HEALTHCARE SOLUTIONS, INC.BYF2024-06-08
00848530093013CPAP KitSUNSET HEALTHCARE SOLUTIONS, INC.BYF2024-06-08
00848530097066CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BYF2024-06-07
00628725095554Pediatric Vari-vent maskCanadian Hospital Specialties LimitedBYF2024-05-16
50628725095559Pediatric Vari-vent maskCanadian Hospital Specialties LimitedBYF2024-05-16
14026704923530RUSCHTELEFLEX INCORPORATEDBYF2024-04-26
24026704923537RUSCHTELEFLEX INCORPORATEDBYF2024-04-26
05030267166060VENTURI VALVE 24% OXYGEN, BLUEIntersurgical IncorporatedBYF2024-04-04
05030267166138VENTURI VALVE 28% OXYGEN, WHITEIntersurgical IncorporatedBYF2024-04-04
05030267166169VENTURI VALVE 35% OXYGEN, YELLOWIntersurgical IncorporatedBYF2024-04-04
05030267166190VENTURI VALVE 40% OXYGEN, REDIntersurgical IncorporatedBYF2024-04-04
05030267166220VENTURI VALVE 60% OXYGEN, GREENIntersurgical IncorporatedBYF2024-04-04
05030267166251VENTURI VALVE 50% OXYGEN, PINKIntersurgical IncorporatedBYF2024-04-04
05030267166282VENTURI VALVE 31% OXYGEN, ORANGEIntersurgical IncorporatedBYF2024-04-04
05030267166077VENTURI VALVE 24% OXYGEN, BLUEIntersurgical IncorporatedBYF2024-04-04
05030267166145VENTURI VALVE 28% OXYGEN, WHITEIntersurgical IncorporatedBYF2024-04-04
05030267166176VENTURI VALVE 35% OXYGEN, YELLOWIntersurgical IncorporatedBYF2024-04-04