FDA.reportPublic FDA data

MIVI Canister Kit

Primary DI
B293MCK15000
Brand
MIVI Canister Kit
Company
MIVI NEUROVASCULAR
Model
MCK-1500
Device description
The MIVI Canister Kit contains a vacuum pump canister and other disposable accessories to be used with a Gomco 405 Aspiration Pump.
Published
2017-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B293MCK15000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA cylindrical or bottle-shaped sealable container intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1500Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
076836823
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B293MIA571120Mi-Axus CatheterMIA-571122016-09-19
B293MIA571300Mi-Axus CatheterMIA-571302016-09-19
B293MIA90800Mi-Axus CatheterMIA90802016-09-28
B293MIA9080S0Mi-Axus CatheterMIA9080S2017-03-15
B293MIA90900Mi-Axus CatheterMIA90902016-09-28
B293MIA9090S0Mi-Axus CatheterMIA9090S2017-03-15
B293MIA9095S0Mi-Axus CatheterMIA9095S2018-02-23
B293MIEXT36370Mi-EXT Distal Access CatheterMi-EXT-36372017-06-01
B293MIEXT43300Mi-EXT Distal Access CatheterMi-EXT-43302017-06-01
B293MIEXT57250Mi-EXT Distal Access CatheterMi-EXT-57252017-06-01
B293MIEXT69250Mi-EXT Distal Access CatheterMi-EXT-69252017-06-01
B293MIEXT6925U0Mi-EXT Distal Access CatheterMi-EXT-6925U2017-09-20
B293Q3361630Q Distal Access CatheterQ3-361632018-07-31
B293Q4431500Q Distal Access CatheterQ4-431502018-12-06
B293Q5571450Q Distal Access CatheterQ5-571452018-12-06
B293Q6691450Q Distal Access CatheterQ6-691452018-07-31
B293HFT1100MIVI High Flow TubingHFT1102017-01-05
B293VR014205G0Vi-RadiusVR014205G2016-09-28
B293VR014300G0Vi-RadiusVR014300G2016-09-28

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