FDA.reportPublic FDA data

O2 Kit

Primary DI
07290017856766
Brand
O2 Kit
Company
FLIGHT MEDICAL INNOVATIONS LTD
Model
KIT-0093
Device description
O2 Kit
Published
2022-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017856766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017856766072900178567667290017856766

GMDN Terms#

Term, Definition table
TermDefinition
Gas cylinder holderA device designed to hold and secure a single medical gas cylinder of compressed medical gas which is to be used in medical treatment/therapy. The usual gases are, [e.g., oxygen (O2), air, or nitrous oxide (N2O)]. It is used to secure the cylinder both during transport and typically whilst the gas is being used. The device is typically constructed of metal and may be mounted to a medical device service rail system, a bed under transport, or other medical devices requiring medical gas to be present. It is configured to meet the size of the cylinder, typically those of small dimensions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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