FDA.reportPublic FDA data

YUWELL Sleep Apnea Breathing Therapy Mask

Primary DI
26922166514178
Brand
YUWELL Sleep Apnea Breathing Therapy Mask
Company
Suzhou Yuyue Medical Technology Co., Ltd.
Model
YN-03 Frame assembly
Catalog number
MA04001
Device description
YN-03 Nasal Mask Parts, Frame assembly
Published
2025-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
26922166514178PackageGS125In Commercial Distribution
06922166514174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2692216651417826922166514178
06922166514174069221665141746922166514174

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.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344011858HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011865HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011872HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011889HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011896HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011902HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011919HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011926HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011933HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011940HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011957HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011964HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
00848530109677CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
00848530109684CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
00198843003606Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003613Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003620Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003637Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003644Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003651Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003668Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003675Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003682Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003699Infant Flow™Zoll Medical CorporationBZD2026-08-14
06970819423212RXiBreeze PAP SystemResvent Medical Technology Co., Ltd.BZD2026-08-14
00850088881097MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881103MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881035IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881042IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881059MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14