FDA UDI
In Commercial Distribution
🇺🇸 United States
Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable
DI: 00195451000355
·
Model: 825Dx
·
Shockwave Medical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable
- Primary DI
- 00195451000355
- Version / Model
- 825Dx
- Catalog Number
- IVLGCCDX
- Company Name
- Shockwave Medical, Inc.
- Labeler DUNS
- 055514478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-22
- Public Version
- 2
- Public Version Date
- 2023-04-05
- Public Version Status
- Update
- Public Device Record Key
- 5c297e9e-f83c-49d1-b1a4-44d5e4939e82
Device Description
The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic arteries.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PPN | Percutaneous Catheter, Ultrasound | Cardiovascular | 870.1250 | 2 |
| QMG | Shockwave Intravascular Lithotripsy System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66730 | Intravascular lithotripsy system generator | An electrically-powered device intended to produce electrical current for transmission to an appropriate catheter (not included) to perform intravascular lithotripsy in peripheral and/or coronary arteries. It typically includes controls, display, and connection cables. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195451000355 | GS1 |
Customer Contacts
- Phone
- 1-877-775-4846
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221041 | 000 |
| P200039 | 006 |
| P200039 | 007 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 65 Degrees Celsius