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
- [email protected]
- Phone
- 616 2598373
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2023-07-18 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2023-07-18 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2024-04-22 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2023-07-18 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2023-07-18 |
| Applicator, Vaginal | HGD | Class 1 | Obstetrics/Gynecology | No | 2023-07-18 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2025-11-19 |
| Tracheal Suction Set | OFS | Class 1 | Anesthesiology | No | 2023-07-20 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2023-07-18 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2023-07-18 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2023-07-18 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2023-07-18 |
| Catheter, Nasal, Oxygen | BZB | Class 1 | Anesthesiology | No | 2023-07-18 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2024-07-03 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2023-07-18 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2018-04-05 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2024-01-04 |
| Skin Prep Tray | OJU | Class 1 | General, Plastic Surgery | No | 2023-07-20 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2023-07-18 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2018-01-18 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2024-07-03 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2023-07-18 |
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2023-07-18 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2023-07-18 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2024-07-03 |
| Oxygen Administration Kit | OGL | Class 2 | Anesthesiology | No | 2023-07-20 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2018-04-09 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2023-07-18 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2018-01-17 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2018-04-05 |
| Thermometer, Clinical Color Change | FQZ | Class 1 | General Hospital | No | 2023-07-18 |
| Cardiopulmonary Resuscitation Aid Kit | OEV | Class 2 | Anesthesiology | No | 2023-07-20 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2018-01-17 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2025-12-12 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2023-07-18 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2023-07-18 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2018-01-17 |
| Calculator, Pulmonary Function Data | BZC | Class 2 | Anesthesiology | No | 2024-04-22 |
| Calculator, Predicted Values, Pulmonary Function | BTY | Class 2 | Anesthesiology | No | 2024-04-22 |
| Plethysmograph, Volume | JEH | Class 2 | Anesthesiology | No | 2024-04-22 |
| System, Rebreathing, Radionuclide | IYT | Class 2 | Radiology | No | 2023-07-18 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2024-07-09 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2013-08-01 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2013-08-01 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2024-09-04 |
| Absorbent, Carbon-Dioxide | CBL | Class 1 | Anesthesiology | No | 2023-07-18 |
| Respiratory Humidifier For Emergency Use | QOP | Class N | Unknown | No | 2023-07-20 |
| Container, Embedding | KER | Class 1 | Pathology | No | 2023-07-18 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2018-01-30 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2018-04-05 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2018-04-05 |
| Conserver, Oxygen | NFB | Class 2 | Anesthesiology | No | 2023-07-18 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2024-04-22 |
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2018-01-30 |
| Humidifier Nebulizer Kit | OGG | Class 2 | Anesthesiology | No | 2023-07-20 |
| Emergency Response Safety Kit | OKI | Class 2 | General, Plastic Surgery | No | 2023-07-20 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2018-01-17 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2023-07-18 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2023-07-18 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2018-04-05 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2018-01-30 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-07-18 |
| Critical Care Ventilator | QOV | Class N | Unknown | No | 2023-07-20 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2018-01-17 |
| Airway Suction Kit | OFO | Class 1 | Anesthesiology | No | 2023-07-20 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2023-07-18 |
| Strip, Temperature, Forehead, Liquid Crystal | KPD | Class 2 | General Hospital | No | 2023-07-18 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2018-01-30 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2024-04-22 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2023-07-18 |
| Ventilator, High Frequency | LSZ | Class 3 | Unknown | No | 2023-07-18 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2018-01-17 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2018-04-09 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2023-07-18 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2023-07-20 |
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