FDA.reportPublic FDA data

Pediatric Aerosol Mask

Primary DI
50628725097010
Brand
Pediatric Aerosol Mask
Company
Respan Products Inc
Model
R-2500
Catalog number
R-2500
Device description
MASK PEDIATRIC AEROSOL FACE
Published
2023-06-30
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
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.

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
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
50628725099564Adult Vari-Vent MaskR-2300SR-2300S2023-06-28
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
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
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