FDA.reportPublic FDA data

Resp-O2 Venturi Adjustable Dial Elongated Adult Mask

Primary DI
00840117310834
Brand
Resp-O2 Venturi Adjustable Dial Elongated Adult Mask
Company
Dynarex Corporation
Model
33072
Device description
7' (2.1m) Crush Resistant Tubing, Standard Connector
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
00840117310841PackageGS150In Commercial Distribution
00840117310834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117310841008401173108418401173108410840117310841
00840117310834008401173108348401173108340840117310834

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
00840117304086Stand Up Cane, Black101392021-09-01
00616784011011Forearm Crutches - Youth, 4'2" - 5'2"101102019-09-30
00616784011110Forearm Crutches - Adult, 5'0" - 6'2"101112019-09-30
00616784011219Forearm Crutches - Tall, 5'10" - 6'6"101122019-09-30
00616784013114Round Handle Cane with Vinyl Grip101312019-09-30
00616784013213Round Handle Cane with Foam Grip101322019-09-30
00616784013312Offset Cane, Black101332019-09-30
00616784013510T-Handle Folding Cane101352019-09-30
00616784013619Quad Cane Small Base, Black101362019-09-30
00616784013718Quad Cane, Large Base, Black101372019-09-30
00616784013817Bariatric Quad Cane, Large Base101382019-09-30
00840117352339Hypodermic Needle, Non-Safety, 20G, 3/4" needles69802019-05-06
00616784910017CurPro Nylon Suture, Black Monofilament, Nonabsorbable, Synthetic91002016-09-24
00616784910116CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91012016-09-24
00616784910215CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91022016-09-24
00616784910314CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91032016-09-24
00616784910413CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91042016-09-24
00616784910611CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91062016-09-24
00616784910710CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91072016-09-24
00616784913018Polyglycolic Acid (PGA) Sutures, Coated Synthetic Absorbable, Violet, Braided91302016-09-24

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