FDA.reportPublic FDA data

Pediatric Aerosol Mask

Primary DI
00628725097015
Brand
Pediatric Aerosol Mask
Company
Canadian Hospital Specialties Limited
Model
R-2500
Catalog number
R-2500
Device description
MASK PEDIATRIC AEROSOL FACE
Published
2023-06-30
Public version status
Update
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
50628725097010PackageGS1100In Commercial Distribution
00628725097015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872509701050628725097010
00628725097015006287250970156287250970150628725097015

GMDN Terms#

Term, Definition table
TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04710969717906Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mL, with Connecting TubeESB-1000FS-TESB-1000FS-T2026-08-18
04710969717913Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLESB-1000SPESB-1000SP2026-08-18
04710969717920Uresil Evolution Connecting TubeESB-STESB-ST2026-08-18
04719899159787Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLESB-1001SPESB-1001SP2026-08-18
04719899159794Uresil Evolution PRE-VAC WOUND DRAINAGE BOTTLEESB-1001FS-TESB-1001FS-T2026-08-18
04719899159824Uresil Evolution Connecting Tube, with SpikeESB-ST1ESB-ST12026-08-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118621137Endure IndustriesENDURE INDUSTRIESBYG2026-08-17
00840118621144Endure IndustriesENDURE INDUSTRIESBYG2026-08-14
04719874950675Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874950972Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951153Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951160Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951177Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951184Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874955793Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874955809Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874955816Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956264Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956271Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956288Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956295Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956301Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956318Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
00607411919039Salter Labs® High Concentration partial rebreatherSALTER LABSBYG2026-06-10
00607411919336Salter Labs® Percent-O2-Lock® MaskSALTER LABSBYG2026-06-10
00607411919008Salter Labs® Adult Comfort Face TentSALTER LABSBYG2026-06-09
00607411919053Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
00607411919060Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
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
00848530108717Nasal CPAP MaskSunset Healthcare Solutions, Inc.BYG2026-04-07
00848530108724Nasal CPAP MaskSunset Healthcare Solutions, Inc.BYG2026-04-07