FDA.reportPublic FDA data

Siesta Full Face Mask Replacement Headgear

Primary DI
06948538362242
Brand
Siesta Full Face Mask Replacement Headgear
Company
BMC Medical Co., Ltd.
Model
NA
Device description
Siesta Full Face Mask Replacement Headgear
Published
2019-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131901000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131901000IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N23B Medical, Inc.2013-12-23BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948538362242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948538362242069485383622426948538362242

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526010310
Device count
1
Lot or batch
true
Manufacturing date on label
true

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
06948538347904Alto 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