FDA Registration
Active
🇲🇽 Mexico
WESTMED de Mexico, S.A de C.V.
Reg #: 9710644
·
FEI: 3003949221
·
Expires 2026
Products
22
Proprietary Names
23
Establishment Types
4
Classifications
22
Registration Details
- Registration Name
- WESTMED de Mexico, S.A de C.V.
- Registration Number
- 9710644
- FEI Number
- 3003949221
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BLVD ENCINO 100, Parque Industrial Tecate
- City
- Tecate Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K881451
Owner / Operator
- Firm Name
- WESTMED, INC.
- Operator Number
- 9048311
- Address
- 5580 S. Nogales Hwy, --
- City
- Tucson
- State
- AZ
- Postal Code
- 85706
- Country
- US
- Correspondent
- Peter Tountas
US Agent
- Business Name
- SunMed Group Holdings, LLC dba AirLife
- Contact Name
- Rob Yamashita
- Address
- 2710 Northridge Dr NW, STE 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 | 2013-03-14 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2004-01-08 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2004-01-08 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2017-06-06 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2008-08-25 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2008-08-26 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2017-09-01 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2021-07-28 |
| Accessory To Continuous Ventilator (Respirator) | MOD | Class 2 | Anesthesiology | No | 2019-07-01 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2019-12-19 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2008-08-26 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2008-06-27 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2004-01-08 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2014-05-09 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2017-09-01 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2009-08-27 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2011-03-31 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2017-09-01 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2012-06-06 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2011-03-31 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2011-03-31 |
| Bottle, Collection And Trap, Breathing System (Uncalibrated) | CBC | Class 2 | General Hospital | No | 2008-09-04 |
Proprietary Names
Heated wick circuit
Clear Anesthesia
CLEAR ANESTHESIA BRE
Circulaire System
ApnealInk ResMed Cannula
Westmed Mask
Nasal Cannula
Neo-Vent
HEPA fILTER w/o CO2 Filter
Anapod
Breathing Bag
Westmed Tubing
Lavabed
Anesthesia Breathing Circuit Kit
Hyperinflation System
Nebulizer
Pedi-lim
Humitube
Uni-lim
Flexi-lim
Humidifier
Westmed
Westmed Collection
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device