FDA Registration
Active
🇲🇽 Mexico
Westmed Javid de Mexico, S.A. de C.V.
Reg #: 3005587132
·
FEI: 3005587132
·
Expires 2026
Products
33
Proprietary Names
36
Establishment Types
3
Classifications
33
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Registration Details
- Registration Name
- Westmed Javid de Mexico, S.A. de C.V.
- Registration Number
- 3005587132
- FEI Number
- 3005587132
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CARRETERA INTERNACIONAL KM 6.5, Edif 18; Parque Industrial Nogales
- City
- NOGALES Sonora
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K953546
Owner / Operator
- Firm Name
- WESTMED, INC.
- Operator Number
- 9082601
- 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
- Peter Tountas
- 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 |
|---|---|---|---|---|---|
| Irrigation Kit (Wounds) | PXY | Class 1 | General, Plastic Surgery | No | 2022-06-08 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2022-05-10 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2015-09-10 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2021-07-28 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2017-09-25 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2017-09-25 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2009-12-16 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2017-09-01 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2017-09-01 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2017-09-01 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2020-04-24 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2017-09-01 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2009-12-16 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2020-06-11 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2009-12-16 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2017-05-19 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2017-03-06 |
| Oxygen Administration Kit | OGL | Class 2 | Anesthesiology | No | 2017-02-14 |
| Arterial Blood Sampling Kit | CBT | Class 1 | Anesthesiology | No | 2012-06-11 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2020-07-08 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2014-08-28 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2009-08-24 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2014-05-09 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2010-08-03 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2019-02-20 |
| Flowmeter, Calibration, Gas | BXY | Class 1 | Anesthesiology | No | 2020-04-22 |
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2011-03-31 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2024-08-09 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2006-06-30 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2012-05-30 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2006-02-03 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2009-12-16 |
| Bottle, Collection And Trap, Breathing System (Uncalibrated) | CBC | Class 2 | General Hospital | No | 2010-08-03 |
Proprietary Names
Wound Irrigation Kit
Manual Pulmonary Resuscitator
Condensation Trap
Salter Labs Bubble Humidifier
CIRCULAIRE II
CIRCULAIRE
A-Line ABG without Needle
Westmed Filter
AirFlow Resuscitator
FloCap
VIXONE
Muc-Away
Airway
ABG
Pulset
Atellica VTR
PEP Device
Anesthesia Breathing Circuit
Humidifier
Westmed tubing
Anesthesia Breathing Circuit Kit
Airway Connector
Hyperinflation System
STAT-Check Resuscitator
Westmed Cannula
Vented Luer Tip Cap
Water Trap
Respiratory Device Accessories
ABG A-Line
Westmed Humidifier
Bag Easy
Breathing Bag
NON-REBREATHER MASK
Westmed Mask
VixOne
Westmed Trap
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)