ClariVein® IC

Primary DI
10854339004010
Brand
ClariVein® IC
Company
VASCULAR INSIGHTS, LLC
Model
45-018-E2S
Catalog number
45-018-E2S
Device description
ClariVein® IC is a specialty infusion cathether with 360 degree rotatable fluid dispersion wire connected to a proximally located integral battery motor drive unit (MDU). The MDU includes the speed selector, handle grip and syringe support features to facilitate physician-controlled infusion of the selected agent. The ClariVein® IC is introduced through a microintroducer. Utilizing vascular imaging, the coaxial catheter sheath with dispersion wire is navigated through the vasculature to the treatment site. Fluid delivered through the catheter assembly's infusion port, surrounds the dispersion wire and exits via an opening at the distal end of the catheter. The ClariVein® IC has no user serviceable parts or capital equipment. It is fully disposable.
Published
2016-09-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30854339004014PackageGS15Not in Commercial Distribution
10854339004010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085433900401430854339004014
1085433900401010854339004010

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Centimeter
Outer Diameter0.0345Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry place

Contacts#

Phone, Email table
PhoneEmail
203-446-5711info@vascularinsights.com

Regulatory Flags#

DUNS number
969986236
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10854339004027ClariVein® IC65-018-E4S65-018-E4S2016-09-19
10854339004034ClariVein® IC85-018-E140S85-018-E140S2016-09-19
10854339004041ClariVein® ICDEMO-45-018-E2SDEMO-45-018-E2S2016-09-19
30854339004014ClariVein® IC45-018-E2S45-018-E2S2016-09-19
30854339004021ClariVein® IC65-018-E4S65-018-E4S2016-09-19
30854339004038ClariVein® IC85-018-E140S85-018-E140S2016-09-19
30854339004045ClariVein® ICDEMO-45-018-E2SDEMO-45-018-E2S2016-09-19

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