FDA.reportPublic FDA data

Ventoux Cuff Extender

Primary DI
07290017856834
Brand
Ventoux Cuff Extender
Company
FLIGHT MEDICAL INNOVATIONS LTD
Model
FLM-0030
Catalog number
FLM-0030
Device description
VX-Cuff Extender
Published
2026-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
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
17290017856831PackageGS110In Commercial Distribution
07290017856834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001785683117290017856831
07290017856834072900178568347290017856834

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Regulatory Flags#

DUNS number
600023576
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07290017856148VentouxVC2 VX-08-1-P00VX-08-1-P002026-04-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102662MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102679MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
08056814676223DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676247DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676254DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676261DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676377DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676384DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676391DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676407DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676360DIMARHMC PREMEDICAL SPACBK2025-03-20
10889483603987AirLife™AIRLIFECBK2025-02-26
10889483603994AirLife™AIRLIFECBK2025-02-26
10889483604007AirLife™AIRLIFECBK2025-02-26
10889483604045AirLife™AIRLIFECBK2025-02-26
10889483604052AirLife™AIRLIFECBK2025-02-26
10889483604069AirLife™AIRLIFECBK2025-02-26
10889483604076AirLife™AIRLIFECBK2025-02-26
10889483604083AirLife™AIRLIFECBK2025-02-26
10889483604090AirLife™AIRLIFECBK2025-02-26