FDA UDI
In Commercial Distribution
🇺🇸 United States
JETi™
DI: 08717648351365
·
Model: WVSDUP
·
ABBOTT VASCULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- JETi™
- Primary DI
- 08717648351365
- Version / Model
- WVSDUP
- Catalog Number
- WVSDUP
- Company Name
- ABBOTT VASCULAR INC.
- Labeler DUNS
- 964569052
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-08
- Public Version
- 4
- Public Version Date
- 2023-03-22
- Public Version Status
- Update
- Public Device Record Key
- c5faf3d1-8e23-4a21-aeb1-a2e7beaa35ba
Device Description
JETi™ Saline Drive Unit
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
- 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 |
|---|---|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | 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 | 08717648351365 | GS1 | ||||
| Previous | B139WVSDUP0 | HIBCC |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius