FDA.reportPublic FDA data

Mediox

Primary DI
00850054612403
Brand
Mediox
Company
Mediox Medical Service Ltd
Model
Standard adult type (L)
Device description
Medical oxygen mask
Published
2023-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850054612403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054612403008500546124038500546124030850054612403

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118843955
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054612342MedioxLengthing adult type (XL)2023-08-24
00850054612359MedioxStandard adult type (L)2023-08-24
00850054612366MedioxLengthening children type (M)2023-08-24
00850054612373MedioxStandard Children type (s)2023-08-24
00850054612380MedioxInfant typee2023-08-24
00850054612397MedioxLengthing adult type (XL)2023-08-24
00850054612410MedioxLengthening children type (M)2023-08-24
00850054612427MedioxStandard Children type (s)2023-08-24
00850054612434MedioxInfant typee2023-08-24
00850054612441MedioxLengthing adult type (XL)2023-08-24
00850054612458MedioxStandard adult type (L) 2023-08-24
00850054612465MedioxLengthening children type (M)2023-08-24
00850054612472MedioxStandard Children type (s)2023-08-24
00850054612489MedioxInfant typee2023-08-24
00850054612496MedioxAdult2023-08-24
00850054612502MedioxChild2023-08-24
00850054612519Medioxlnfant2023-08-24
00850054612526MedioxAdult2023-08-24
00850054612533MedioxChild2023-08-24
00850054612540Medioxlnfant2023-08-24

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