FDA UDI Not in Commercial Distribution 🇺🇸 United States

JETi All In One Saline Drive Unit

DI: B139WVSDUP0 · Model: WVSDUP · WALK VASCULAR L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
JETi All In One Saline Drive Unit
Primary DI
B139WVSDUP0
Version / Model
WVSDUP
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
d767acbf-8903-4ff4-a481-c0f572ca3612
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
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
QEZ Aspiration Thrombectomy Catheter

GMDN Terms

Code Name
58214 Mechanical atherectomy/thrombectomy drive system

Identifiers

Type ID
Package WVSDUP2
Primary B139WVSDUP0