Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013576541

FEI Number

3013576541

Entity Name

Jiangxi Yiles Medical Co., Ltd

City/State/Country

Nanchang City Jiangxi, CN

Establishment Address

Chuangye Road 1199, Jinxian, Nanchang City Jiangxi 331700, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangxi Yiles Medical Co., Ltd (Owner Number: 10053724)

Owner / Operator Contact Address

Chuangye Road 1199, Jinxian,, Nanchang Cityc, CN-JX 331700, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Heat And Moisture Exchanger Filter Nasal Oxygen Cannula For Single Use Oxygen Mask For Single Use Closed Suction Catheter For Single Use; Nelaton Catheter For Single Use; Suction Catheter For Single Use Urine Bag For Single Use Breahting Circuit For Single Use Anaethesia Mask For Single Use Guedel Airway For Single Use; Laryngeal Mask Airway Nebulizer Mask For Single Use Nagophryngeal Tube For Single Use

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2017-01-05
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2017-01-05
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2017-01-05
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2017-01-05
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2017-01-05
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2017-01-05
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2017-01-05
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2017-01-05
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2017-01-05
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2017-01-05

Official Correspondent

Xiaoting Jiang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Jiangxi Yiles Medical 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 3013576541. Last updated year: 2026. Please use registration number 3013576541 when referencing this establishment in official correspondence.