FDA.reportPublic FDA data

VENTURI VALVE 50% OXYGEN, PINK

Primary DI
05030267166251
Brand
VENTURI VALVE 50% OXYGEN, PINK
Company
Intersurgical Incorporated
Model
1400050
Device description
VENTURI VALVE 50% OXYGEN, PINK
Published
2024-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
05030267166268PackageGS150In Commercial Distribution
05030267166275PackageGS1200In Commercial Distribution
05030267166251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05030267166268050302671662685030267166268
05030267166275050302671662755030267166275
05030267166251050302671662515030267166251

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.

Contacts#

Phone, Email table
PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags#

DUNS number
785952607
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05030267169870I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US)82010302026-06-02
05030267169894I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.0, SMALL PAEDIATRIC, 10-25KG (US)82020302026-06-02
05030267169917I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)82030302026-06-02
05030267169931I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)82040302026-06-02
05030267169955I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)82050302026-06-02
05030267169979I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.5, INFANT, 5-12KG (US)82150302026-06-02
05030267169993I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.5, LARGE PAEDIATRIC, 25-35KG (US)82250302026-06-02
05030267170012I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)89030302026-06-02
05030267170036I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)89040302026-06-02
05030267170050I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)89050302026-06-02
05030267089123FIXED ELBOW, 15M - 22M/15F - STERILE1997000S2026-04-28
05030267169542SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER11430352026-04-21
05030267169573SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH TUBE, 2.1M USA ONLY11410352026-04-21
05030267169597SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER11430382026-04-21
05030267169634SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO MONITORING LINE AND TUBE11420352026-04-21
05030267056057Y-PIECE 22M, 22M, 22M/15F19000002021-10-12
05030267056095Y-PIECE 22M, 22M, 22M/15F WITH PORTS19010002021-10-12
05030267056118Y-PIECE 15M, 15M, 15F19020002021-10-12
05030267056132Y-PIECE 15M, 15M, 22M/15F + 7.6MM PORTS, PAEDIATRIC19030002021-10-12
05030267056347PARALLEL Y-PIECE, 22MM19260002021-10-12

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
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
05030267166206VENTURI VALVE 40% OXYGEN, REDIntersurgical IncorporatedBYF2024-04-04