FDA.reportPublic FDA data

PEDIATRIC HIGH CONCENTRATION OXYGEN MASK

Primary DI
00628725099750
Brand
PEDIATRIC HIGH CONCENTRATION OXYGEN MASK
Company
Canadian Hospital Specialties Limited
Model
R-2650
Catalog number
R-2650
Device description
PEDIATRIC HIGH CONCENTRATION OXYGEN MASK
Published
2024-11-07
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
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50628725099755PackageGS150In Commercial Distribution
00628725099750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872509975550628725099755
00628725099750006287250997506287250997500628725099750

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
Serial number
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
04816415501379LARYNGEAL MASK Single Use Size 2ASSOMEDIKA, OOOBYG2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3ASSOMEDIKA, OOOBYG2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467462HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10889483221662Performance Home MedicalSUNMED, LLCBYG2025-12-31
10889483227268BiFLo™SUNMED, LLCBYG2025-12-30
10889483227275BiFLo™SUNMED, LLCBYG2025-12-30
10889483223970AirLife™SUNMED, LLCBYG2025-12-19
10889483224151AirLife™SUNMED, LLCBYG2025-12-19
10889483224298DeVilbissSUNMED, LLCBYG2025-12-19
10889483224687AirLife™SUNMED, LLCBYG2025-12-19
10889483224168AirLife™SUNMED, LLCBYG2025-12-18
10197344011117HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011742HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011759HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011773HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344042203HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011582HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011599HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011605HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011612HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344009626HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06
10197344010646HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06