FDA Registration Active 🇲🇽 Mexico

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

Reg #: 8030673 · FEI: 3004213967 · Expires 2026
Products
75
Proprietary Names
177
Establishment Types
5
Classifications
75

Registration Details

Registration Name
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
Registration Number
8030673
FEI Number
3004213967
Status
Active
Expiry Year
2026
Initial Importer
No
Address
CERRADA VIA DE LA PRODUCCION, No. 85 PARQUE INDUST.MEXICALI III
City
MEXICALI Baja California
Country
MX

Regulatory Submissions

510(k) Number
K153234

Owner / Operator

Firm Name
SunMed Group Holdings, LLC dba AirLife
Operator Number
10044795
Address
2710 Northridge Drive NW, Suite A
City
Grand Rapids
State
MI
Postal Code
49544
Country
US
Correspondent
Rob Yamashita

US Agent

Business Name
AirLife
Contact Name
Rob Yamashita
Address
2710 Northridge Drive NW - Suite A
City
Grand Rapids
State
MI
ZIP
49544
Country
US
Phone
616 2598373

Products

Device Name Product Code
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
Accessory, Surgical Apparel LYU
Ventilator, Non-Continuous (Respirator) BZD
Valve, Non-Rebreathing CBP
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Applicator, Vaginal HGD
Humidifier, Non-Direct Patient Interface (Home-Use) KFZ
Tracheal Suction Set OFS
Ventilator, Emergency, Manual (Resuscitator) BTM
Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
Applicator, Absorbent Tipped, Non-Sterile KXF
Catheter, Irrigation GBX
Catheter, Nasal, Oxygen BZB
Ventilator, Continuous, Facility Use CBK
Attachment, Breathing, Positive End Expiratory Pressure BYE
Connector, Airway (Extension) BZA
Filter, Bacterial, Breathing-Circuit CAH
Skin Prep Tray OJU
Tubing, Noninvasive GAZ
Set, Tubing And Support, Ventilator (W Harness) BZO
Nebulizer (Direct Patient Interface) CAF
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Tube Tracheostomy And Tube Cuff JOH
Tube, Tracheal (W/Wo Connector) BTR
Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
Oxygen Administration Kit OGL
Bag, Reservoir BTC
Tray, Surgical LRP
Condenser, Heat And Moisture (Artificial Nose) BYD
Clip, Nose BXJ
Thermometer, Clinical Color Change FQZ
Cardiopulmonary Resuscitation Aid Kit OEV
Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
Mixer, Breathing Gases, Anesthesia Inhalation BZR
Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
Mask, Oxygen, Low Concentration, Venturi BYF
Mask, Gas, Anesthetic BSJ
Calculator, Pulmonary Function Data BZC
Calculator, Predicted Values, Pulmonary Function BTY
Plethysmograph, Volume JEH
System, Rebreathing, Radionuclide IYT
Dressing, Wound, Drug FRO
Infusor, Pressure, For I.V. Bags KZD
Blood Pressure Cuff DXQ
Bronchoscope (Flexible Or Rigid) EOQ
Absorbent, Carbon-Dioxide CBL
Respiratory Humidifier For Emergency Use QOP
Container, Embedding KER
Cannula, Nasal, Oxygen CAT
Forceps HTD
Mask, Oxygen, Non-Rebreathing KGB
Conserver, Oxygen NFB
Tube, Aspirating, Flexible, Connecting BYY
Drain, Tee (Water Trap) BYH
Humidifier Nebulizer Kit OGG
Emergency Response Safety Kit OKI
Tubing, Pressure And Accessories BYX
Spirometer, Therapeutic (Incentive) BWF
Catheters, Suction, Tracheobronchial BSY
Stylet, Tracheal Tube BSR
Laryngoscope, Rigid CCW
Continuous Measurement Thermometer FLL
Critical Care Ventilator QOV
Mask, Oxygen BYG
Airway Suction Kit OFO
Mouthpiece, Breathing BYP
Strip, Temperature, Forehead, Liquid Crystal KPD
Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
Electrocardiograph DPS
Support, Patient Position CCX
Ventilator, High Frequency LSZ
Device, Fixation, Tracheal Tube CBH
Support, Breathing Tube JAY
Catheter And Tip, Suction JOL
Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP

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 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 APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED Tube tracheostomy and tube cuff Nebulizer Airlife Nebulizer Tube, tracheal BL HEATER, BREATHING SYSTEM W/WO CONTROLLER Oxygen administration kit Reservoir Bag Circuits Heated Wire TRAY, SURGICAL BreathTech HME Medline HME Ventlab HME CONDENSER, HEAT AND MOISTURE Nose Clip THERMOMETER, CLINICAL COLOR CHANGE Cannulas Etco2 Cardiopulmonary resuscitation aid kit Circuit, breathing (w/ connector, adapter, y piece) Circuit, Breathing (W connector, adaptor, Y piece) Ambu Hyperinflation System 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 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 VixOne Medisorb™ Multi-Absorber Original, Disposable ABSORBENT, CARBON-DIOXIDE Medisorb™ EX, Disposable Respiratory humidifier for emergency use CONTAINER, EMBEDDING 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 Oxygen Mask Conserver, oxygen Cannulas O2 TUBE, ASPIRATING, FLEXIBLE, CONNECTING DRAIN, TEE (WATER TRAP) Adapters And Connectors (Ventilation Accessories) Humidifier nebulizer kit WaterPAP Ventilator, continuous, facility use Emergency response safety kit Ventlab Pressure Tubing and Accessories SPIROMETER, THERAPEUTIC CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) 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 Thermometer, electronic, clinical Critical care ventilator MiniHEART Nebulizer Ventlab Oxygen Mask Mixer, breathing gases, anesthesia inhalation Resuscitation Bags Flow-Inflating Airway suction kit Ventlab BV Filter Medline BV Filter BreathTech BV Filter Owens&Minor Breathing Circuit with Ventlab B/V Filter MedLine HME Filter AirFlow Resuscitator VCare Resuscitator MOUTHPIECE, BREATHING STRIP, TEMPERATURE, FOREHEAD, LIQUID CRYSTAL NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) SUPPORT, PATIENT POSITION Ventilator, non-continuous Face Mask Neonate and Infant Disposable Ventilator, emergency, manual (resuscitator) VENTILATOR, HIGH FREQUENCY Superno2va Nasal Interface Manual Pulmonary Resuscitator DEVICE, FIXATION, TRACHEAL TUBE Dressing, wound, drug Breathing Tube Support Tube Tree CATHETER AND TIP, SUCTION FLEXTUBES Uni-Heart BlockAid Pulmonary Function Filter Anesthesia breathing circuit kit (adult & pediatric) Circuits Anesthesia O2 Delivery Adapters And Connectors Humidifiers Heated

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198