ClariVein® IC DEMO-45-018-E2S
GUDID 30854339004045
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. DEMO UNIT.
VASCULAR INSIGHTS, LLC
Peripheral vascular infusion catheter| Primary Device ID | 30854339004045 |
| NIH Device Record Key | 364538e2-8537-4fe9-8d4b-3c66638dc812 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClariVein® IC |
| Version Model Number | DEMO-45-018-E2S |
| Catalog Number | DEMO-45-018-E2S |
| Company DUNS | 969986236 |
| Company Name | VASCULAR INSIGHTS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
| Length | 45 Centimeter |
| Outer Diameter | 0.0345 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10854339004041 [Primary] |
| GS1 | 30854339004045 [Package] Contains: 10854339004041 Package: case [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071468
FDA Product Code
| KRA | Catheter, Continuous Flush |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2016-09-19 |
On-Brand Devices [ClariVein® IC]
| 30854339004045 | ClariVein® IC is a specialty infusion cathether with 360 degree rotatable fluid dispersion wire |
| 30854339004038 | ClariVein® IC is a specialty infusion cathether with 360 degree rotatable fluid dispersion wire |
| 30854339004021 | ClariVein® IC is a specialty infusion cathether with 360 degree rotatable fluid dispersion wire |
| 30854339004014 | ClariVein® IC is a specialty infusion cathether with 360 degree rotatable fluid dispersion wire |
Trademark Results [ClariVein]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLARIVEIN 77552610 3733262 Live/Registered |
Vascular Insights LLC 2008-08-21 |
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