FDA.reportPublic FDA data

Adult Vari-Vent Mask

Primary DI
50628725099564
Brand
Adult Vari-Vent Mask
Company
Respan Products Inc
Model
R-2300S
Catalog number
R-2300S
Device description
MASK ADULT VARIVENT 6 DILUTERS W/ 7' SAFLO OXYGEN TUBING
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
50628725099564PackageGS150In Commercial Distribution
00628725099569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872509956450628725099564
00628725099569006287250995696287250995690628725099569

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-825 9300regulatory.affairs@chsltd.com

Regulatory Flags#

DUNS number
243175213
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
50628725096983TavishR-7700SR-7700S2023-07-06
50628725097058Adult Nasal Cannula-Vinyl R-1701MR-1701M2023-07-06
5062872509726319mm Magenta Tubing Connector RPN-R-2980MRPN-R-2980M2023-07-06
50628725097010Pediatric Aerosol MaskR-2500R-25002023-06-30
50628725097027JemsdalA-251A-2512023-06-30
50628725098284TavishR-7200SR-7200S2023-06-30
50628725099489Adult Oxygen MaskR-2100R-21002023-06-30
50628725099793Pediatric High Concentration Oxygen MaskR-2750SR-2750S2023-06-30
50628725099809Pediatric Three-In-One MaskR-2755SR-2755S2023-06-30
50628725097256Corrugated TubingR-4020R-40202023-06-28
50628725097447Oxygen WrenchR-3040R-30402023-06-28
50628725098086Corrugated TubingR-4011-12R-4011-122023-06-28
50628725098192T-PieceR-6402R-64022023-06-28
50628725099540Adult Three-In-One Mask with 7' Saflo TubeR-2255SR-2255S2023-06-28
50628725099557Adult Three-In-One Mask with Multi-fit Connector on 7' Saflo TubeR-2255SMR-2255SM2023-06-28
50628725097348Adult NSA Oxygen MaskR-9001R-90012023-06-27
50628725097393Security ChainR-3030R-30302023-06-27
50628725097409PPE CPAP Smoothbore TubingR-4420-72/50R-4420-72/502023-06-27
50628725097416Pediatric Aerosol MaskR-2500/50R-2500/502023-06-27
50628725097539Corrugated TubingR-4020BR-4020B2023-06-27

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