FDA UDI
Not in Commercial Distribution
🇺🇸 United States
JETi Saline Drive Unit
DI: B139WV00071
·
Model: WV0007
·
WALK VASCULAR L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- JETi Saline Drive Unit
- Primary DI
- B139WV00071
- Version / Model
- WV0007
- Catalog Number
- WV0007
- Company Name
- WALK VASCULAR L.L.C.
- Labeler DUNS
- 034774488
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-17
- Public Version
- 5
- Public Version Date
- 2022-09-27
- Public Version Status
- Update
- Public Device Record Key
- 42ffff6e-e1e2-4153-b5bb-5c1c37674b1d
- Distribution End Date
- 2017-11-20
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| DXE | Catheter, Embolectomy | Cardiovascular | 870.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58214 | Mechanical atherectomy/thrombectomy drive system | A multi-purpose assembly of devices designed to power and control the mechanical mechanism of an atherectomy and/or thrombectomy catheter (not included) during an intravascular recanalization procedure. It typically consists of an electrically-powered control unit that supplies the drive motor with electricity to power the catheter and a handpiece with hand-switch that includes the drive motor (for catheter manipulation); a foot-switch may also be included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B139WV00071 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- – 681 Millimeter of Mercury