Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R) 014RRH

GUDID 00850065047003

Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R) for Medline Renewal

Vein360 LLC

Intravascular ultrasound imaging catheter, reprocessed

• Primary Device ID: 00850065047003
• NIH Device Record Key: 5cd44535-95bd-4332-a94b-b21b87c7b912
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)
• Version Model Number: 014RRH
• Catalog Number: 014RRH
• Company DUNS: 080926907
• Company Name: Vein360 LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850065047003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232584

FDA Product Code

• OWQ: Reprocessed Intravascular Ultrasound Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-12
• Device Publish Date: 2024-08-02

On-Brand Devices [Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)]

• 00860036000517: Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)
• 00850065047003: Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R) for Medline Renewal