Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015134079

FEI Number

3015134079

Entity Name

IVEMSA S.A. de C.V DIVISION AG INDUSTRIES

City/State/Country

Tijuana Baja California, MX

Establishment Address

Andador vecinal 12001, suite L2-A, Colonia Carretera Tijuana- Tecate, Tijuana Baja California 22253, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AG Industries (Owner Number: 9041666)

Owner / Operator Contact Address

12755 Olive Boulevard, --Suite 201, Saint Louis, MO 63141, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AG Circuit, breathing (w connector, adaptor, y piece) AG Disinfectant, medical devices AG Filter, bacterial, breathing-circuit AG Flowmeter, tube, thorpe, back-pressure compensated AG FLOWMETER, CALIBRATION, GAS AG STRAP, HEAD, GAS MASK

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	2017-01-05
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2017-01-05
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2006-01-19
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2019-10-21
BXY	Flowmeter, Calibration, Gas	Anesthesiology	Class 1	868.2350	2019-10-21
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2015-09-11

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Given Business: AG Industries Email: michael.selva@filtrationgroup.com Phone: (470) 2979893

Related Public Records

Same Entity

AG Industries

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004874794	AG INDUSTRIES LLC	Fairburn, GA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

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

Similar Registrations

Registration Number	Establishment Name	Location
9680661	Mallinckrodt Dar S.r.l.	MIRANDOLA Modena, IT
2523320	Keystone Industries	Myerstown, PA, US
9616445	VADI Medical Technology Co., Ltd.	Taoyuan City, TW
3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
3038562397	Respironics Medical Products (Shenzhen) Co., Ltd.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015134079. Last updated year: 2026. Please use registration number 3015134079 when referencing this establishment in official correspondence.