Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014208300

FEI Number

3014208300

Entity Name

HITEC MEDICAL CO., LTD

City/State/Country

Shanghai, CN

Establishment Address

No. 501, Building 2 Lane 1505, Lian Hang Road, Minhang District, Shanghai 201112, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hitec Medical Co., Ltd (Owner Number: 10062211)

Owner / Operator Contact Address

No. 501, Building 2 Lane 1505, Lian Hang Road, Minhang District, Shanghai, CN-SH 201112, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Multi-vent mask Urine bag Non-rebreath mask Oropharyngeal airway Bougie Nasopharyngeal airway Anesthesia & Breathing circuit Suction catheter Connecting tube with yankauer handle Suction connecting tube Tracheal tube fixer Intubating stylet Closed Suction catheter Nasal oxygen cannula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2020-01-15
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2020-01-15
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2020-01-15
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2020-01-15
KBI	Bougie, Eustachian	Ear, Nose, Throat	Class 1	874.4175	2020-01-15
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2020-01-15
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2020-01-15
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2020-01-15
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2020-01-15
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2020-01-15
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2023-11-27
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2020-01-15
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2023-08-24
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2020-01-15

Official Correspondent

Jackie Sheng

US Agent Details

Phoenix Wang Email: wcy_2@hotmail.com Phone: (405) 6945955

Related Public Records

Same Entity

Hitec Medical 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
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
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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3004134948	ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.	Huzhou City Zhejiang, CN
3015821396	JCMED TIANJIN IMPORT AND EXPORT CO., LTD	Tianjin, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014208300. Last updated year: 2026. Please use registration number 3014208300 when referencing this establishment in official correspondence.