JETi Saline Drive Unit

GUDID B139WV034511

WALK VASCULAR L.L.C.

Mechanical atherectomy/thrombectomy drive system

• Primary Device ID: B139WV034511
• NIH Device Record Key: 54e0077d-fe4a-44f7-85a0-f70db3c577ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JETi Saline Drive Unit
• Version Model Number: WV0345-1
• Company DUNS: 034774488
• Company Name: WALK VASCULAR L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B139WV034510 [Primary]
HIBCC	B139WV034511 [Package]; Contains: B139WV034510; Package: Case [1 Units]; In Commercial Distribution

FDA Product Code

• QEZ: Aspiration Thrombectomy Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-25
• Device Publish Date: 2019-06-17

On-Brand Devices [JETi Saline Drive Unit]

• B139WV034011: WV0340-1
• B139WV03401: WV0340
• B139WV00081: WV0008
• B139WV00071: WV0007
• B139WV034511: WV0345-1
• B139WV03451: WV0345