JETi All In One Non-Sterile Kit

GUDID 08717648351389

WALK VASCULAR L.L.C.

Surgical irrigation/aspiration tubing set

• Primary Device ID: 08717648351389
• NIH Device Record Key: b858b9ad-f74b-487f-a672-963629c6bb01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JETi All In One Non-Sterile Kit
• Version Model Number: WV1500A
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
GS1	08717648351389 [Primary]
HIBCC	B139WV1500A1 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201998

FDA Product Code

• KDQ: Bottle, Collection, Vacuum
• 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: 2021-12-16
• Device Publish Date: 2021-12-08

On-Brand Devices [JETi All In One Non-Sterile Kit]

• B139WV1500A2: WV1500A
• 08717648351389: WV1500A