Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005767446

FEI Number

3005767446

Entity Name

NINGBO SHENGYURUI MEDICAL APPLIANCE CO.

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

NO.138 Binhaisi Road, Hangzhou Bay New Zone, Ningbo Zhejiang 315336, CN

Establishment Type(s)

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

Owner / Operator

NINGBO SHENGYURUI MEDICAL APPLIANCE CO. (Owner Number: 9091901)

Owner / Operator Contact Address

No138Binhaisi Road,Hangzhou Bay New Zone, --, NingBo City, ZHEJIANG PROVINCE, CN-ZJ 315336, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Anesthetic Breating Circuit ( Gas Sampling Line, Breathing Bag) cannula Yankauer Suction handle Breating Circuit (Dual Limb Breating Circuit, Catheter Mount, Single Limb Breating Circuit, J Circuit) Two Way Manifold

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2020-05-07
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2006-09-06
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2010-04-27
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2007-06-18
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2006-09-06
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2015-09-08
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2006-09-06
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2020-09-04

Official Correspondent

LUO Linna

US Agent Details

Matt Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

NINGBO SHENGYURUI MEDICAL APPLIANCE CO.

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 3005767446. Last updated year: 2026. Please use registration number 3005767446 when referencing this establishment in official correspondence.