FDA Registration
Active
🇫🇷 France
INT'AIR MEDICAL
Reg #: 3030149975
·
FEI: 3030149975
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- INT'AIR MEDICAL
- Registration Number
- 3030149975
- FEI Number
- 3030149975
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 868 CHEMIN DE LA ZA DES METRILLOTS
- City
- MONTAGNAT Ain
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K163283
Owner / Operator
- Firm Name
- INT'AIR MEDICAL
- Operator Number
- 10091244
- Address
- 868 CHEMIN DE LA ZA DES METRILLOTS
- City
- MONTAGNAT
- State
- Ain
- Postal Code
- 01250
- Country
- FR
- Correspondent
- SIMON WEST
US Agent
- Business Name
- Hamilton Medical, Inc.
- Contact Name
- Robert Hamilton
- Address
- 4655 Aircenter Cir
- City
- Reno
- State
- NV
- ZIP
- 89502
- Country
- US
- [email protected]
- Phone
- 800 4266331 ext. 210
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2024-07-31 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2024-07-31 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2024-07-31 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2024-07-31 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-07-31 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2024-07-31 |
Proprietary Names
Cover Plug for ID15
Red Cover Cap
Breathing circuit set, coaxial, single use, adult/pediatric PN 260167, PN 260168, PN 260145, PN 260144, PN 260087
Breathing circuit sets, dual limb, single use, neonatal PN 260180, PN 260182, PN 250169, PN 260170
Breathing circuit sets, dual limb, single use, neonatal/pediatric PN 260241, PN 260244
Breathing circuit set, coaxial, single use, adult/pediatric PN 260207, PN 260239, PN 260240, PN 260257
Breathing circuit set, coaxial, single use, adult/pediatric PN 260094, PN 260127, PN 260128, PN 260184, PN 260206
Establishment Types
Export Device to the United States But Perform No Other Operation on Device