FDA.reportPublic FDA data

Resp-O2 Venturi Select A Vent Elongated Mask

Primary DI
00840117310797
Brand
Resp-O2 Venturi Select A Vent Elongated Mask
Company
Dynarex Corporation
Model
33070
Device description
With 7 Dilutors, 7' (2.1 m) Crush Resistant Tubing, Standard Connector, Adult
Published
2021-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117339057Durma+ Transparent Film Dressing, Frame Style, Sterile36472024-12-13
00840117339088Durma+ Transparent Film Dressing, Frame Style36482024-12-13
00616784319438Compress Bandages, Offset, Sterile31942021-06-21
00840117307360Child Face Masks2207-CHCR2021-06-21
00616784245119SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24512026-10-01
00616784245218SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24522026-10-01
00616784316925Cotton Balls, Large31692026-10-01
00616784317021Cotton Balls, Medium31702026-10-01
00616784671628SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrou67162026-09-30
00616784671727SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67172026-09-30
00616784671826SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67182026-09-30
00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67192026-09-30
00840117346147Resp-O2 M24 Oxygen E-Cylinder, With CGA 870 Toggle Valve, 4.55 L36390-TBULK2026-09-28
00840117346154Resp-O2 M15 Oxygen Standard D-Cylinder, With CGA 870 Toggle Valve36391-TBULK2026-09-28
00840117346239Resp-O2 M15 Oxygen Standard D-Cylinder, With CGA 870 Post Valve36391-PBULK2026-09-28
00840117320987Resp-O2 Suction Canister Rings, Compatible With 800 cc and 1200 cc Canister324092026-09-25
00840117352735dmecare Solutions Folding Beside Commode103702021-04-22
00840117352742dmecare Solutions Elongated Folding Bedside Commode103712021-04-22
00840117308855Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL342212022-05-11
00616784431321Junior Tongue Depressors, 5 1/2" (14.0 cm)43132021-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816286021199Boehringer Venturi Oxygen Valve InletBOEHRINGER LABORATORIES, LLCBYF2026-09-22
04719874950996Create BiotechCREATE BIOTECH CO., LTD.BYF2026-07-21
04719874951009Create BiotechCREATE BIOTECH CO., LTD.BYF2026-07-21
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