FDA.reportPublic FDA data

Responsive Respiratory

Primary DI
00851440007780
Brand
Responsive Respiratory
Company
RESPONSIVE RESPIRATORY, INC.
Model
220-3523
Device description
Pediatric Oxygen Mask, Medium Concentration
Published
2024-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00851440007780PrimaryGS10
10851440007787Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851440007780008514400077808514400077800851440007780
1085144000778710851440007787

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.

Regulatory Flags#

DUNS number
129132747
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851440007483Responsive Respiratory, Inc.200-01222025-12-13
00851440007841Responsive Respiratory, Inc.150-1145E2025-12-13
00851440007858Responsive Respiratory, Inc.150-1121E2025-12-13
00851440007865Responsive Respiratory, Inc.150-1500-56652025-12-13
00851440007803Responsive Respiratory, Inc.150-02402025-01-22
00851440007810Responsive Respiratory, Inc.150-02502025-01-22
00851440007827Responsive Respiratory, Inc.150-0246N2025-01-22
00851440007834Responsive Respiratory, Inc.150-01102025-01-22
00851440007629Responsive Respiratory220-36042024-08-01
00851440007636Responsive Respiratory220-36072024-08-01
00851440007643Responsive Respiratory220-36252024-08-01
00851440007650Responsive Respiratory220-37572024-08-01
00851440007667Responsive Respiratory220-30072024-08-01
00851440007681Responsive Respiratory220-30252024-08-01
00851440007698Responsive Respiratory220-30502024-08-01
00851440007704Responsive Respiratory220-35752024-08-01
00851440007711Responsive Respiratory220-3575-H2024-08-01
00851440007728Responsive Respiratory220-32102024-08-01
00851440007735Responsive Respiratory220-32152024-08-01
00851440007742Responsive Respiratory220-32212024-08-01

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