FDA.reportPublic FDA data

YUWELL Sleep Apnea Breathing Therapy Mask

Primary DI
26922166510668
Brand
YUWELL Sleep Apnea Breathing Therapy Mask
Company
Suzhou Yuyue Medical Technology Co., Ltd.
Model
YF-03 (M)
Device description
YF-03 Full Face Mask - medium, for single-patient use.
Published
2021-10-15
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203347000Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow MaskSuzhou Yuyue Medical Technology Co., Ltd.2021-07-02BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26922166510668PackageGS110In Commercial Distribution
06922166510664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2692216651066826922166510668
06922166510664069221665106646922166510664

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
421307196
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06922166514174YUWELL Sleep Apnea Breathing Therapy MaskYN-03 Frame assemblyMA040012025-12-23
26922166514178YUWELL Sleep Apnea Breathing Therapy MaskYN-03 Frame assemblyMA040012025-12-23
06922166514082YUWELL Standard conical connectorTP-012025-10-21
06922166514068HeadgearH5MA020042025-10-10
06922166514075YUWELL Sleep Apnea Breathing Therapy MaskYP-01 FrameMA030032025-10-10
06922166513948YUWELL Sleep Apnea Breathing Therapy MaskYN-03 (M)MN030172025-10-09
06922166513955YUWELL Sleep Apnea Breathing Therapy MaskYN-03 (L)MN030182025-10-09
06922166513962YUWELL Sleep Apnea Breathing Therapy MaskYN-03 (XL)MN030192025-10-09
06922166513979YUWELL Sleep Apnea Breathing Therapy MaskYN-03 Cushion (S)MA010242025-10-09
06922166513986YUWELL Sleep Apnea Breathing Therapy MaskYN-03 Cushion (M)MA010252025-10-09
06922166513993YUWELL Sleep Apnea Breathing Therapy MaskYN-03 Cushion (L)MA010262025-10-09
06922166514006YUWELL Sleep Apnea Breathing Therapy MaskYN-03 Cushion (XL)MA010272025-10-09
06922166514013YUWELL Sleep Apnea Breathing Therapy MaskYN-03 FrameMA030022025-10-09
06922166514020YUWELL Sleep Apnea Breathing Therapy MaskYP-01 (Fit pack)MP010102025-10-09
06922166514037YUWELL Sleep Apnea Breathing Therapy MaskYP-01 Cushion (S)MA010282025-10-09
06922166514044YUWELL Sleep Apnea Breathing Therapy MaskYP-01 Cushion (M)MA010292025-10-09
06922166514051YUWELL Sleep Apnea Breathing Therapy MaskYP-01 Cushion (L)MA010302025-10-09
06922166513801YUWELL Sleep Apnea Breathing Therapy MaskYF-02 (Fit pack)MF020112025-09-30
06922166513818YUWELL Sleep Apnea Breathing Therapy MaskYF-02 (S)MF020122025-09-30
06922166513825YUWELL Sleep Apnea Breathing Therapy MaskYF-02 (M)MF020132025-09-30

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