FDA.reportPublic FDA data

Pediatric Vari-vent mask

Primary DI
00628725095554
Brand
Pediatric Vari-vent mask
Company
Canadian Hospital Specialties Limited
Model
R-2800S
Catalog number
R-2800S
Device description
PEDIATRIC VARI-VENT Mask, 6 Jets - 24% to 50%, Aerosol Hood, 7FT Saflo Tube
Published
2024-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
50628725095559PackageGS150In Commercial Distribution
00628725095554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872509555950628725095559
00628725095554006287250955546287250955540628725095554

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
9058259300Regulatory.affairs@chsltd.com

Regulatory Flags#

DUNS number
240992693
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628725095295MiniMuffs0402160403412025-04-11
00628725096940Nebulizer KitMS-6920S2024-02-23
00628725097336VixOne™ Nebulizer KitR-6415VR-6415V2023-06-16
00628725097688RespanR-7420SR-7420S2023-06-22
00628725097695Pediatric Nebulizer KitR-6920SR-6920S2023-06-15
00628725097732Adult Nebulizer KitMS-6420SMS-6420S2023-06-15
00628725098173VixOne™ Nebulizer KitR-6400R-64002023-06-15
00628725098203VixOne™ Nebulizer Kit R-6405SR-6405S2024-08-20
00628725098210VixOne™ Nebulizer KitR-6415SR-6415S2023-06-15
00628725098234VixOne™ Nebulizer KitR-6420SR-6420S2023-06-15
00628725098500VixOne™ Nebulizer KitR-8420SR-8420S2023-06-15
00628725095073MISI-Medical Imaging Solutions International100301T100301T2025-09-11
00628725095080MISI-Medical Imaging Solutions International1002011002012025-09-11
00628725095103MISI-Medical Imaging Solutions International2001012001012025-09-11
00628725095165MISI-Medical Imaging Solutions International2002012002012025-09-11
00628725095172MISI-Medical Imaging Solutions International200107D200107D2025-09-11
00628725095189MISI-Medical Imaging Solutions International200101i200101i2025-09-11
00628725095196MISI-Medical Imaging Solutions International200301A200301A2025-09-11
00628725095219MISI-Medical Imaging Solutions International200105A200105A2025-09-11
50628725095078MISI-Medical Imaging Solutions International100301T100301T2025-09-11

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