Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015168843

FEI Number

3015168843

Entity Name

INTERSURGICAL MEDICAL APPARATUS (CHANGZHOU) CO., LTD.

City/State/Country

Changzhou City Jiangsu, CN

Establishment Address

No. 1011, Liaohe Road, Xinbei District, Changzhou City Jiangsu 213125, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Intersurgical Medical Apparatus (Changzhou) Co., Ltd. (Owner Number: 10059558)

Owner / Operator Contact Address

No. 1011, Liaohe Road, Xinbei District, Changzhou City, CN-JS 213125, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

high concentration oxygen mask, 1192000 3504000, Superset Straight Connector Flexible straight catheter mount, 3511000 Flexible fixed elbow catheter mount, 3501000, 3502000 Clear-Guard Midi low volume breathing filter with luer port, 1644000 Smoothbore tube, 5005000, 5018000 2920010, 2920310 2158000 Pulmo-Protect lung function filter 1691011, 1691012, 1691016, 1691013, 1691014, 1691009 1691000, 1691001, 1691002, 1691003, 1691004, 1691005, 1691006, 1691007, 1691050, 1691051, 1691052, 1691053, 1691010 adult high concentration oxygen mask, 1181015 adult medium concentration oxygen mask, 1135015, 1135017, 1136015 Sentri EcoLite, 1141015 Clear-Guard 3 breathing filter, 1544000 Flo-Guard Breathing Filter, 1690000 2731000, 2734000, 2734100, 2725000, 1142015, 1142016, 1143015, 1143017, 1143018 Venturi Valve, 1400024, 1400028, 1400031, 1400035, 1400040, 1400050, 1400060

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2022-11-07
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2022-05-12
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2023-05-09
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2025-04-21
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2022-05-25
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2022-11-07
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2022-11-07
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2022-11-07
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-03-21
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2025-04-21

Official Correspondent

Ivan Seniut

US Agent Details

Kerrie Campbell Business: Intersurgical Inc Email: kcampbell@intersurgicalinc.com Phone: (315) 4512900

Related Public Records

Same Entity

Intersurgical Medical Apparatus (Changzhou) 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
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26

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 3015168843. Last updated year: 2026. Please use registration number 3015168843 when referencing this establishment in official correspondence.