FDA.reportPublic FDA data

YUWELL Sleep Apnea Breathing Therapy Mask

Primary DI
06922166514013
Brand
YUWELL Sleep Apnea Breathing Therapy Mask
Company
Suzhou Yuyue Medical Technology Co., Ltd.
Model
YN-03 Frame
Catalog number
MA03002
Device description
YN-03 Nasal Mask Parts, Frame
Published
2025-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
26922166514017PackageGS150In Commercial Distribution
06922166514013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2692216651401726922166514017
06922166514013069221665140136922166514013

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, reusableA flexible, form-shaped device designed to be placed over a user's nose 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. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Regulatory Flags#

DUNS number
421307196
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
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
06922166513832YUWELL Sleep Apnea Breathing Therapy MaskYF-02 (L)MF020142025-09-30

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Primary DI, Brand, Company table
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00850088881028ItAllShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-09
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00198843003569Infant Flow™Zoll Medical CorporationBZD2026-06-24
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00198843003583Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003590Infant Flow™Zoll Medical CorporationBZD2026-06-24
00814747024935MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024942MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024959MiniMe 2 Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024966MiniMe 2 Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024973Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024980Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024997Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747025000Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109042CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109059CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109066CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00814747024850Novaplus Pediatric Nasal Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-06-03
00814747024867Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-03
00814747024874Novaplus Pediatric Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-06-03
00814747024881Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-03