Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000604079

FEI Number

1000604079

Entity Name

VINCENT MEDICAL MANUFACTURING. CO., LTD.

City/State/Country

KOWLOON, HK

Establishment Address

FLAT/RM B2,7/F,HANG FUNG INDUSTRIAL BUILDING, PHASE 2,2G HOK YUEN STREET,HUNG HOM, KOWLOON --, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

VINCENT MEDICAL MANUFACTURING. CO., LTD. (Owner Number: 10041038)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123896

PMA Number

N/A

All Registered Proprietary Names

Inspired Ventilation Circuits including Adult/ Prediatric ventilaation circuit including PVC tube, pressure monitor line Inspired Medical nCPAP Patient Interface including Adult / Pediatric Silicone Circuit including resuable catheter Inspired Medical Limbo Circuit iincluding connectors Inspired Meidcal Coaxial Circuit including Coaxial anesthesia circuit, expanable tube, connectors Inspired Medical Smoothbore Ventilation Circuits including Adult Smoothbore cirucit including Adult Siingle Limb, exhala Inpsired Medical Adult Anaesthesia Breathing System including drapable/expandable tubing, connectors, spare limb Inpsired Medical Prediatric Anaesthesia Breathing System including hoses, connectors, spare limb Inspired Medical Reusable Hytrel Circuits including Adult single / dual limb hytrel circuit, exhalation valve Adult (22mm) Single limb Smoothbore + 3 Way exhalation valve (VM version) Adult (22mm) Single limb corrugated + 3 Way exhalation valve (VM version) Pediatric (15mm) Single limb corrugated + 3 way exhalation valve (VM version) Pediatric (15mm) Single limb Smoothbore + 3 way exhalation valve (VM version) BAG TUBE, ADULT, REUSABLE, HYTREL, 1.5m Pressure Hose Assemblies (DISS) Air Cushion Masks for neonate, infant, pediatric, child, small adult, large adult RW Resuscitaire Inspired Medical breathing bag: 0.5L / 1L / 2L / 3L

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2012-06-14
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2015-02-02
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2012-06-14
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2014-09-15
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2014-09-15
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2014-09-15
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2014-09-15
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2014-09-15
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2014-09-15
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2014-09-15
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2014-09-15
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2014-09-15
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2014-09-15
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2012-06-14
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2015-09-10
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2012-06-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2018-05-14
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2025-06-02
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2012-06-14
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2017-01-10
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2020-07-26
NFB	Conserver, Oxygen	Anesthesiology	Class 2	868.5905	2013-01-31
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2012-06-14
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2013-02-03
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-11-10
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2024-11-10
NFB	Conserver, Oxygen	Anesthesiology	Class 2	868.5905	2013-01-31
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2012-06-14
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2013-01-31
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2019-08-01
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2019-08-01
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2019-08-01
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2019-08-01
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2019-08-01
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2019-08-01
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2019-08-01
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2013-01-31
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2026-03-15
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2012-06-14
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2014-11-18
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2016-06-01
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2013-01-31
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2012-06-14
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2012-06-14
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2012-06-14
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2012-06-14
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-01-31
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2013-05-25
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2021-02-16
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2013-01-31
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2017-03-28

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
K050853	Card Guard Scientific Survival , Ltd.	PMP4 SPIROPRO	2005-05-04
K123945	Monaghan Medical Corp.	STRIVE DUAL ZONE PEAK FLOW METER	2013-04-17
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K812140	3M Company	BIRD MEAN AIRWAY PRESSURE MONITOR	1981-08-20
K040917	Philips Medizin Systeme Boeblingen GmbH	PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B	2004-04-29

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-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
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000604079. Last updated year: 2026. Please use registration number 1000604079 when referencing this establishment in official correspondence.