Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit
Basic Information
- Brand Name
- Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit
- Primary DI
- 00857595006180
- Version / Model
- TVC-E195-42
- Catalog Number
- TVC-E195-42
- Company Name
- INFRAREDX, INC.
- Labeler DUNS
- 124065421
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-11
- Public Version
- 1
- Public Version Date
- 2022-11-21
- Public Version Status
- New
- Public Device Record Key
- 7ae642c3-914f-4de7-867e-2438cf01edb2
Device Description
The Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit (TVC-E195-42) is a single use, disposable coronary and peripheral imaging catheter and accessory kit designed for use only with the Makoto Intravascular Imaging System™ (TVC-MC10 and TVC-MC10i). The high definition intravascular ultrasound imaging catheter combines 50 MHz Extended Bandwidth IVUS transducer for acquisition of vessel structure. The Infraredx Clarispro™ HD-IVUS Imaging Catheter features a durable hydrophilic coating for improved deliverability. Indications for Use: 1. The Makoto Intravascular Imaging System™ is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. b. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OGZ | Catheter, Intravascular, Plaque Morphology Evaluation | Cardiovascular | 870.1200 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44141 | Intravascular ultrasound imaging catheter, single-use | A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857595006180 | GS1 | ||||
| Package | 10857595006187 | GS1 | Carton | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 888-680-7339
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight