FDA.reportPublic FDA data

Ventoux

Primary DI
07290017856148
Brand
Ventoux
Company
FLIGHT MEDICAL INNOVATIONS LTD
Model
VC2 VX-08-1-P00
Catalog number
VX-08-1-P00
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223120000Ventoux VC2; Ventoux VC3Flight Medical Innovations , Ltd.2024-12-02CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017856145PackageGS11In Commercial Distribution
07290017856148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001785614517290017856145
07290017856148072900178561487290017856148

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose intensive-care ventilatorA 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).

Regulatory Flags#

DUNS number
600023576
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017856834Ventoux Cuff ExtenderFLM-0030FLM-00302026-04-23
07290017856049VentouxVC2 VX-08-0-MN0VX-08-0-MN02026-04-21
07290017856056VentouxVC2 VX-08-0-PN0VX-08-0-PN02026-04-21
07290017856063VentouxVC2 VX-08-0-001VX-08-0-0012026-04-21
07290017856070VentouxVC2 VX-08-0-M01VX-08-0-M012026-04-21
07290017856087VentouxVC2 VX-08-0-P01VX-08-0-P012026-04-21
07290017856094VentouxVC2 VX-08-0-0N1VX-08-0-0N12026-04-21
07290017856100VentouxVC2 VX-08-0-MN1VX-08-0-MN12026-04-21
07290017856117VentouxVC2 VX-08-0-PN1VX-08-0-PN12026-04-21
07290017856124VentouxVC2 VX-08-1-000VX-08-1-0002026-04-21
07290017856131VentouxVC2 VX-08-1-M00VX-08-1-M002026-04-21
07290017856155VentouxVC2 VX-08-1-0N0VX-08-1-0N02026-04-21
07290017856162VentouxVC2 VX-08-1-MN0VX-08-1-MN02026-04-21
07290017856179VentouxVC2 VX-08-1-PN0VX-08-1-PN02026-04-21
07290017856186VentouxVC2 VX-08-1-001VX-08-1-0012026-04-21
07290017856193VentouxVC2 VX-08-1-M01VX-08-1-M012026-04-21
07290017856209VentouxVC2 VX-08-1-P01VX-08-1-P012026-04-21
07290017856216VentouxVC2 VX-08-1-0N1VX-08-1-0N12026-04-21
07290017856223VentouxVC2 VX-08-1-MN1VX-08-1-MN12026-04-21
07290017856230VentouxVC2 VX-08-1-PN1VX-08-1-PN12026-04-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
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