FDA UDI
Not in Commercial Distribution
🇺🇸 United States
JETi All In One Accessory Cart
DI: B139WVCART0
·
Model: WVCART
·
WALK VASCULAR L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- JETi All In One Accessory Cart
- Primary DI
- B139WVCART0
- Version / Model
- WVCART
- 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
- 2021-02-26
- Public Version
- 3
- Public Version Date
- 2022-09-27
- Public Version Status
- Update
- Public Device Record Key
- 0a0b5cfd-890e-452d-bc08-7aa1261e49be
- Distribution End Date
- 2021-12-08
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
- No
- 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 |
|---|---|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | Cardiovascular | 870.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35124 | Medical device integration rack | A device that is designed as an instrument rack (maybe cabinet-like with closed sides) and is used for mounting and organizing several medical devices that are intended to interact (integrated instrumentation). It is typically mobile (on wheels) and has built-in grounded outlets, pull-out shelves, working surfaces, and may even be equipped with a built-in transformer. This device, when supplied with the instrumentation fitted, will become a system and will require product identification of the whole as a system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B139WVCART2 | HIBCC | 1 | Not in Commercial Distribution | 2021-12-08 | |
| Primary | B139WVCART0 | HIBCC |