Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004050971

FEI Number

3004050971

Entity Name

VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD.

City/State/Country

Dong Guan City Guangdong, CN

Establishment Address

11 Shabu Street, Qiao Long District, Tang Xia Town, Dong Guan City Guangdong 523730, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

VINCENT MEDICAL MANUFACTURING CO., LTD. (Owner Number: 9051073)

Owner / Operator Contact Address

FLAT/RM B2, 7/F., HANG FUNG INDUSTRIAL BUILDING, PHASE2,2G HOK YUEN STREET, HUNG HOM,, Kowloon, HK-NOTA --, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RW Resuscitaire Inspired Reusable Breathing Circuit VentStar humidifier chamber (N) Air Cushion Masks for neonate, infant, pediatric, child, small adult, large adult BAG TUBE, ADULT, REUSABLE, HYTREL, 1.5m VentStar Heated/ Infinity ID Breathing Circuit Heated

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2013-01-31
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2007-12-10
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2007-02-06
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2005-04-19
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2008-02-28
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2023-08-07
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2005-04-19
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2018-03-23
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2018-03-23
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2018-03-23
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2018-03-23
NFB	Conserver, Oxygen	Anesthesiology	Class 2	868.5905	2013-01-31
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2014-09-12
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2016-06-01
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2005-04-19
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2026-03-15
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2005-04-19
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2020-11-15
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2008-02-28
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2008-02-28
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2008-02-28
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2008-03-12
NFB	Conserver, Oxygen	Anesthesiology	Class 2	868.5905	2013-01-31
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2024-11-10
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2018-05-14
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2010-11-07
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2015-02-02
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-01-30
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2017-03-28
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2024-07-25

Official Correspondent

Thomas Chan

US Agent Details

MAXWELL SIDNER Email: maxsidner@cox.net Phone: (949) 8880395

Related Public Records

Same Entity

VINCENT MEDICAL MANUFACTURING CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020219	Replacement Parts Industries, Inc.	RPI SKIN OR AIR TEMPERATURE PROBE	2002-04-12
K881713	Gempco, Inc.	SPECIAL PROCEDURES BASE UNIT MODEL 500	1988-07-12
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K103392	Inovo, Inc.	CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER	2010-12-17
K812140	3M Company	BIRD MEAN AIRWAY PRESSURE MONITOR	1981-08-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004050971. Last updated year: 2026. Please use registration number 3004050971 when referencing this establishment in official correspondence.