Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030673

FEI Number

3004213967

Entity Name

PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.

City/State/Country

MEXICALI Baja California, MX

Establishment Address

CERRADA VIA DE LA PRODUCCION, No. 85 PARQUE INDUST.MEXICALI III, MEXICALI Baja California 21397, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SunMed Group Holdings, LLC dba AirLife (Owner Number: 10044795)

Owner / Operator Contact Address

2710 Northridge Drive NW, Suite A, Grand Rapids, MI 49544, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER ACCESSORY, SURGICAL APPAREL VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Valve, non-rebreathing ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE APPLICATOR, VAGINAL AirLife Bubble Humidifier Tracheal suction set Ventilator, emergency, manual Westmed GSL (Salter) Tubing/tubing with filter, insufflation, laparoscopic Water Solutions Saline And Sterile CATHETER, IRRIGATION CATHETER, NASAL, OXYGEN Masks Non-Invasive Full Face And Nasal Attachment, breathing, positive end expiratory pressure Ventilator, emergency, manual CONNECTOR, AIRWAY Westmed Breathing Circuits Nox Medical Filter Skin prep tray TUBING, NONINVASIVE Filter, bacterial, breathing-circuit Patient Circuits And Accessories Non-Heated Ventilator Set Nebulizers Large Volume Prefilled And Dry Water Solutions Saline And Sterile Attachment, breathing, positive end expiratory pressure APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED Tube tracheostomy and tube cuff Nebulizer Airlife Nebulizer Tube, tracheal BL HEATER, BREATHING SYSTEM W/WO CONTROLLER Water Solutions Saline And Sterile Oxygen administration kit Reservoir Bag HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER Circuits Heated Wire TRAY, SURGICAL BreathTech HME Medline HME Ventlab HME CONDENSER, HEAT AND MOISTURE Nose Clip THERMOMETER, CLINICAL COLOR CHANGE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Cannulas Etco2 Nebulizer Nebulizer Cardiopulmonary resuscitation aid kit Nebulizer Circuit, breathing (w/ connector, adapter, y piece) Circuit, Breathing (W connector, adaptor, Y piece) HEATER, BREATHING SYSTEM W/WO CONTROLLER Circuits Heated Wire Ambu Hyperinflation System Filter, bacterial, breathing-circuit MONITOR, AIRWAY PRESSURE MASK, OXYGEN, LOW CONCENTRATION, VENTURI Vent Mask II Breath Tech Mask Soft-Aire Mask Vent Mask Westmed Anesthesia Masks MASK, GAS, ANESTHETIC HUMIDIFIER, RESPIRATORY GAS CALCULATOR, PULMONARY FUNCTION DATA CALCULATOR, PULMONARY FUNCTION DATA Nebulizer MASK, GAS, ANESTHETIC ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE System, rebreathing, radionuclide Wound Flash, Sterile Water & Normal Saline HEART Nebulizer Infu-Surg Pressure Infusion Bag Surgi-Press Ventlab Pressure Infusion Bag Clarity Infu-Surg Pressure Infusion Bag Integrity Pressure Infusion Bag Zefon InfuseIT Pressure Infusion Bag InfuseOne Pressure Infusion Bag Vital Signs Pressure Infuser Blood Pressure Cuff Bronchoscope Ventilator, emergency, manual Nebulizer VixOne Medisorb Multi-Absorber Original, Disposable ABSORBENT, CARBON-DIOXIDE Medisorb EX, Disposable HEATER, BREATHING SYSTEM W/WO CONTROLLER Circuits Heated Wire Respiratory humidifier for emergency use Nebulizer CONTAINER, EMBEDDING Filter, bacterial, breathing-circuit PFT Filters AirLife GSL Oxygen Cannula Oxygen Masks Oxygen Tubing Mask Face Tent Disp CANNULA, NASAL, OXYGEN Mask Air Entrain Adult W/u-connect-it Mouthpiece Universal Poly Disp Mask Aerosol Hi-concent Disp Under Chin Etco2 Cannula 7' U/connect-it Adult,male Cannula Crvd N-flr Tip W/o Tb Disp Adapter Trach T Westmed GSL Forceps Nebulizers Large Volume Prefilled And Dry ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Circuits Heated Wire Oxygen Mask Nebulizer Ventilator, emergency, manual Conserver, oxygen Cannulas O2 TUBE, ASPIRATING, FLEXIBLE, CONNECTING DRAIN, TEE (WATER TRAP) Nebulizer Adapters And Connectors (Ventilation Accessories) Nebulizer ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Ventilator, emergency, manual Humidifier nebulizer kit WaterPAP HUMIDIFIER, RESPIRATORY GAS Nebulizer Ventilator, continuous, facility use Nebulizer Emergency response safety kit Ventlab Pressure Tubing and Accessories Oxygen Tubing Filter, bacterial, breathing-circuit SPIROMETER, THERAPEUTIC Attachment, breathing, positive end expiratory pressure CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) Nebulizers Large Volume Prefilled And Dry Ballard Metered Dose Inhaler (MDI) Adapter CATHETERS, SUCTION, TRACHEOBRONCHIAL Ballard Single Dose Vials, 0.9% Sodium Chloride Solution SunSlip Stylette with Sheath Ported ET Tube Introducer SunGlide Stylette ET Tube Introducer Aluminum Disposable Stylette Fiber Optic Stylette Stainless Steel Stylette Lighted Stylette Solid Copper Stylette Malleable Introducer Hollow Copper Stylette Aluminum Stylette PVC Stylette Coated Stylette GreenLine®/D LED Conventional Laryngoscope Handle GreenLine® Disposable Fiber Optic Laryngoscope Handle GreenLine® Fiber Optic Laryngoscope Handle GreenLine®/D Fiber Optic Laryngoscope Handle GreenLine® Disposable Fiber Optic Laryngoscope Blade Conventional Laryngoscope Blade GreenLine®/D Fiber Optic Laryngoscope Blade Conventional Disposable Laryngoscope Handle Conventional Laryngoscope Handle GreenLine® Fiber Optic Laryngoscope Blade Fiber Optic Laryngoscope Blade Conventional Disposable Laryngoscope Blade SunOne System Laryngoscope Handle SunOne System Laryngoscope Blade Fiber Optic Laryngoscope Handle GreenLine®/D LED Disposable Laryngoscope Handle GreenLine®/D LED Laryngoscope Blade Blade, Laryn, Vs, Plastic, Mil 2 & 3 Blade, Laryn, Vs, Plastic, Mac 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2023-07-18
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2023-07-18
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-04-22
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2023-07-18
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-07-18
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2023-07-18
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2025-11-19
OFS	Tracheal Suction Set	Anesthesiology	Class 1	868.6810	2023-07-20
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2023-07-18
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-02-11
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2023-07-18
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2023-07-18
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2023-07-18
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2023-07-18
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-07-03
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2023-07-18
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2023-07-18
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2018-04-05
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2024-01-04
OJU	Skin Prep Tray	General, Plastic Surgery	Class 1	878.4800	2023-07-20
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2023-07-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2023-07-18
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2018-01-18
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2024-07-03
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2023-07-18
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2023-07-18
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2023-07-18
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-18
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2025-12-11
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2023-07-18
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2023-07-18
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2023-07-18
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2024-07-03
OGL	Oxygen Administration Kit	Anesthesiology	Class 2	868.5655	2023-07-20
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2018-04-09
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2023-07-18
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-07-18
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2018-01-17
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2018-04-05
FQZ	Thermometer, Clinical Color Change	General Hospital	Class 1	880.2900	2023-07-18
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-07-18
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-18
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-18
OEV	Cardiopulmonary Resuscitation Aid Kit	Anesthesiology	Class 2	868.5915	2023-07-20
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-18
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2018-01-17
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2023-07-18
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2025-12-12
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2023-07-18
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2023-07-18
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2023-07-18
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2018-01-17
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2023-07-18
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2024-04-22
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2024-04-22
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2024-04-22
JEH	Plethysmograph, Volume	Anesthesiology	Class 2	868.1760	2024-04-22
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-18
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2023-07-18
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-07-18
IYT	System, Rebreathing, Radionuclide	Radiology	Class 2	892.1390	2023-07-18
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-07-09
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2024-09-26
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2013-08-01
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2013-08-01
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-09-04
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2023-07-18
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-18
CBL	Absorbent, Carbon-Dioxide	Anesthesiology	Class 1	868.5300	2023-07-18
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2023-07-18
QOP	Respiratory Humidifier For Emergency Use	Unknown	Class N	N/A	2023-07-20
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-18
KER	Container, Embedding	Pathology	Class 1	864.3010	2023-07-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2023-07-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2024-08-23
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2025-12-11
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2018-01-30
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2024-05-30
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2024-05-30
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2018-04-05
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-07-18
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2024-07-03
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2018-04-05
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-18
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2023-07-18
NFB	Conserver, Oxygen	Anesthesiology	Class 2	868.5905	2023-07-18
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2024-04-22
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2018-01-30
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-18
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-18
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-07-18
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2023-07-18
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2023-07-20
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2025-12-11
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2024-09-04
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-18
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2023-07-18
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-18
OKI	Emergency Response Safety Kit	General, Plastic Surgery	Class 2	878.4040	2023-07-20
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2018-01-17
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2023-07-18
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2023-07-18
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2023-07-18
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2024-04-22
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2024-04-22
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2023-07-18
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2018-04-05
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2024-08-09
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2024-08-09
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2018-01-30

Official Correspondent

Rob Yamashita

US Agent Details

Rob Yamashita Business: AirLife Email: ryamashita@myairlife.com Phone: (616) 2598373

Related Public Records

Same Entity

SunMed Group Holdings, LLC dba AirLife

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010362947	Shenzhen Vital Signs-KTL Medical Instrument Co Ltd	Shenzhen Guangdong, CN
3030308442	SUNMED GROUP HOLDINGS, LLC dba AirLife	Litchfield Park, AZ, US
8030647	Westmed de Mexico, S.A de C.V	MAGDALENA Sonora, MX
3006606984	Westmed de Mexico, S.A de C.V	NOGALES Sonora, MX
1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
K945177	Eagle Health Supplies	4-O2 JR. (CPR MOUTH BARRIER)	1994-11-01
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01

Similar Registrations

Registration Number	Establishment Name	Location
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
9710644	WESTMED de Mexico, S.A de C.V.	Tecate Baja California, MX
3023272766	CEVA LOGISTICS LIMITED	Daventry Northamptonshire, GB
3014766741	Hamilton Medical AG	Domat / Ems Graubunden, CH
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030673. Last updated year: 2026. Please use registration number 8030673 when referencing this establishment in official correspondence.