FDA.reportPublic FDA data

YUWELL Standard conical connector

Primary DI
06922166514082
Brand
YUWELL Standard conical connector
Company
Suzhou Yuyue Medical Technology Co., Ltd.
Model
TP-01
Device description
O2 T-Pipe
Published
2025-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BZAConnector, Airway (Extension)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26922166514086PackageGS150In Commercial Distribution
06922166514082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2692216651408626922166514086
06922166514082069221665140826922166514082

GMDN Terms#

Term, Definition table
TermDefinition
Y-piece breathing circuit connector, reusable"A connecting device shaped in the form of a ""Y"" and designed to connect compatible components [e.g., the tubing and face mask or an endotracheal (ET) tube] to create a breathing circuit. In order to function this device will be part of a breathing circuit and will typically connect the inspiratory and expiratory sides at the point of entry into the patient. It will typically be used during anaesthesia and/or ventilation and is made of durable materials, e.g., plastic and/or metal. This is a reusable device."

Regulatory Flags#

DUNS number
421307196
Device count
1
Premarket exempt
true
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
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

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Primary DI, Brand, Company table
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04719874957551Create BiotechCREATE BIOTECH CO., LTD.BZA2026-07-21
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10197344012435HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
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10197344012473HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-12-12
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00848530098261VENTILATOR ACCESSORYSunset Healthcare Solutions, Inc.BZA2025-08-28
00848530107246Oxygen Connector/AdapterSunset Healthcare Solutions, Inc.BZA2025-08-19
10197344042432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-08-18
10884521854147DARCovidien LPBZA2025-08-10
00848530106317Ventilator CircuitSunset Healthcare Solutions, Inc.BZA2025-07-15
00848530106324Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530106331Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530106348Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530060299Oxygen Connector/AdapterSunset Healthcare Solutions, Inc.BZA2025-06-03
00848530097363Ventilator AccessorySunset Healthcare Solutions, Inc.BZA2025-05-21