FDA.reportPublic FDA data

Patient Circuit

Primary DI
17290013641585
Brand
Patient Circuit
Company
FLIGHT MEDICAL INNOVATIONS LTD
Model
V64-50010-60
Device description
F60 SL Single Use PC
Published
2017-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use
NOUContinuous, Ventilator, Home Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2
NOUContinuous, Ventilator, Home UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120726000FLIGHT 60 VENTILATORFlight Medical Innovations , Ltd.2012-07-06CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290013641585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729001364158517290013641585

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. 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 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600023576
Device count
1
Lot or batch
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
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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00814747025253Novaplus Full Face AAV Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025260Novaplus Full Face AAV Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
00814747025277Novaplus Full Face Non Vented Mask, Extra LargeSLEEPNET, CORP.CBK2026-10-23
00814747025284Novaplus Full Face Non Vented Mask, LargeSLEEPNET, CORP.CBK2026-10-23
00814747025291Novaplus Full Face Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025307Novaplus Full Face Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
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