FDA.reportPublic FDA data

Boehringer Venturi Oxygen Valve Inlet

Primary DI
10816286021199
Brand
Boehringer Venturi Oxygen Valve Inlet
Company
BOEHRINGER LABORATORIES, LLC
Model
3960
Device description
Boehringer Venturi Oxygen Valve Inlet
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
30816286021193PackageGS15In Commercial Distribution
10816286021199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081628602119330816286021193
1081628602119910816286021199

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen/air breathing gas mixer, hospitalAn independent mechanical device designed for accurate mixing of air and oxygen (O2) with O2 concentrations ranging from 21% to 100% (oxygen/air proportioner) that are appropriated for breathing in patients who need a concentration of O2 above the normal concentration in air. The mixer receives air and oxygen from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. The mixer may deliver the gas to the patient through devices such as ventilators, tracheostomy tubes, endotracheal (ET) tubes, oxygen tents, and/or masks.

Contacts#

Phone, Email table
PhoneEmail
610-278-0900info@boehringerlabs.com

Regulatory Flags#

DUNS number
079991657
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
true
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
10816286021182Boehringer Surgical Suction Device50302025-11-24
20816286021189Boehringer Surgical Suction Device50302025-11-24
10816286021175UpLivt 52002025-07-16
70816286021177UpLivt 52002025-07-16
10816286021120BOEHRINGER® ViSiGi Lux 36 Fr5336SB2025-05-20
10816286021137BOEHRINGER® ViSiGi Lux 40 Fr5340SB2025-05-20
30816286021124BOEHRINGER® ViSiGi Lux 36 Fr5336SB2025-05-20
30816286021131BOEHRINGER® ViSiGi Lux 40 Fr5340SB2025-05-20
10816286021151BOEHRINGER® CareDry™ Male System76802024-12-31
20816286021158BOEHRINGER® CareDry™ Male System76802024-12-31
10816286021168BOEHRINGER® Offset Mount - Four Inches90612024-12-31
10816286021076BOEHRINGER® CareDry™ System76602021-11-01
10816286020659BOEHRINGER® Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System52502016-08-01
10816286021083TruLim Length Indicating Device501050102022-06-21
10816286020932BOEHRINGER® Smoke Removal System57002020-02-01
10816286020079BOEHRINGER® Care 4™ Suction Regulator, Intermittent/Continuous, 0-200, off/ cont384438442016-08-01
10816286021144BOEHRINGER® CareDry™ System76652023-12-29
20816286021141BOEHRINGER® CareDry™ System76652023-12-29
10816286020949BOEHRINGER® CareDry™ Regulator PST763076302020-01-15
10816286021014BOEHRINGER® Disposable Regulator 100-150mmHg765076502020-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05030267166077VENTURI VALVE 24% OXYGEN, BLUEIntersurgical IncorporatedBYF2024-04-04