FDA.reportPublic FDA data

Alto Full Face Mask

Primary DI
06948538347904
Brand
Alto Full Face Mask
Company
BMC Medical Co., Ltd.
Model
F6S(Large)
Device description
Alto Full Face Mask(M Tube)
Published
2026-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16948538347901PackageGS120In Commercial Distribution
06948538347904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694853834790116948538347901
06948538347904069485383479046948538347904

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, reusableA 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 and/or 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 reusable device.

Regulatory Flags#

DUNS number
526010310
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
06948538347683Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347690Alto Nasal Pillows InterfaceP6S (Small)2026-10-15
06948538347706Alto Nasal Pillows InterfaceP6S (Medium)2026-10-15
06948538347713Alto Nasal Pillows InterfaceP6S(Large)2026-10-15
06948538347720Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347737Alto Nasal Pillows InterfaceP6S(Small)2026-10-15
06948538347744Alto Nasal Pillows InterfaceP6S(Medium)2026-10-15
06948538347751Alto Nasal Pillows InterfaceP6S(Large)2026-10-15
06948538347768Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347775Alto Nasal Pillows InterfaceP6S(Small)2026-10-15
06948538347782Alto Nasal Pillows InterfaceP6S(Medium)2026-10-15
06948538347799Alto Nasal Pillows InterfaceP6S(Large)2026-10-15
06948538347805Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347812Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347829Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347836Alto Full Face MaskF6S (All Size Kit)2026-10-15
06948538347843Alto Full Face MaskF6S (Small)2026-10-15
06948538347850Alto Full Face MaskF6S (Medium)2026-10-15
06948538347867Alto Full Face MaskF6S(Large)2026-10-15
06948538347874Alto Full Face MaskF6S (All Size Kit)2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948538347683Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347690Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347706Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347713Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347720Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347737Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347744Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347751Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347768Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347775Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347782Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347799Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347805Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347812Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347829Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347836Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347843Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347850Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347867Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347874Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347881Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347898Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347911Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347928Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347935Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347942Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347959Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347966Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347973Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347980Alto Nasal MaskBMC Medical Co., Ltd.BZD2026-10-15