FDA.reportPublic FDA data

Ventoux Patient Circuit

Primary DI
07290017856490
Brand
Ventoux Patient Circuit
Company
FLIGHT MEDICAL INNOVATIONS LTD
Model
VX64-0002
Catalog number
VX64-0002
Device description
VX-DL Adult Single Use P.C.
Published
2026-04-21
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
17290017856497PackageGS110In Commercial Distribution
07290017856490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001785649717290017856497
07290017856490072900178564907290017856490

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. 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
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198843002852bellavistaZoll Medical CorporationCBK2026-07-10
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00198843001145bellavistaZoll Medical CorporationCBK2026-06-24
00198843001152bellavistaZoll Medical CorporationCBK2026-06-24
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
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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
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