JETi Thrombectomy System, Sterile Disposable Components Kit

Basic Information

• Brand Name: JETi Thrombectomy System, Sterile Disposable Components Kit
• Primary DI: B139WV600311
• Version / Model: WV6003-1
• 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: 2019-02-08
• Public Version: 3
• Public Version Date: 2022-09-27
• Public Version Status: Update
• Public Device Record Key: 825eb94d-de19-4d04-b703-c736723fcf87
• Distribution End Date: 2020-11-07

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

GMDN Terms

Code	Name	Definition	Implantable	Status
36142	Aspiration tray, single-use	A container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B139WV600312	HIBCC	Corrugated Box	5	Not in Commercial Distribution	2020-11-07
Primary	B139WV600311	HIBCC

Device Sizes

Type	Value	Unit	Text
Catheter Length	120	Centimeter
Catheter Gauge	6	French