FDA UDI
In Commercial Distribution
🇺🇸 United States
Ventoux
DI: 07290017856322
·
Model: VC3 VX-12-0-P01
·
FLIGHT MEDICAL INNOVATIONS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ventoux
- Primary DI
- 07290017856322
- Version / Model
- VC3 VX-12-0-P01
- Catalog Number
- VX-12-0-P01
- Company Name
- FLIGHT MEDICAL INNOVATIONS LTD
- Labeler DUNS
- 600023576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-21
- Public Version
- 1
- Public Version Date
- 2026-04-29
- Public Version Status
- New
- Public Device Record Key
- 3940ae08-5a10-4530-8a2d-7c9db5db525d
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47244 | General-purpose intensive-care ventilator | A mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for a patient, excluding neonates or small infants, in various clinical uses. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290017856329 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 07290017856322 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223120 | 000 |