Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013550220

FEI Number

3013550220

Entity Name

Ningbo Great Mountain Medical Instruments Co.,Ltd

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

No.309 Xigu Road Xiangshan District, Ningbo Zhejiang 315100, CN

Establishment Type(s)

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

Owner / Operator

Ningbo Great Mountain Medical Instruments Co.,Ltd (Owner Number: 10054423)

Owner / Operator Contact Address

No.309 Xigu Road Xiangshan District, Ningbo, CN-ZJ 315100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Device, fixation, tracheal tube Anaethsia breathing circuit, anaethsia breathing ciruict kit OXYGEN MASK; AEROSOL MASK; Tracheostomy Mask collection bottle MASK, OXYGEN, NON-REBREATHING AIRWAY, OROPHARYNGEAL Humidifier Bottle, Disposable Bubble humidifiers MASK, GAS, ANESTHETIC nasal oxygen cannula Suction Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2025-06-24
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2026-03-27
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2017-03-16
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2022-01-20
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2017-03-16
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2017-03-16
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2025-09-10
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2026-03-27
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2017-03-16
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2026-05-08

Official Correspondent

Jacky Yang

US Agent Details

Jason Zhou Email: ShamrockIE49@hotmail.com Phone: (626) 6325067

Related Public Records

Same Entity

Ningbo Great Mountain Medical Instruments Co.,Ltd

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013550220. Last updated year: 2026. Please use registration number 3013550220 when referencing this establishment in official correspondence.