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

GUDID 00860036000517

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

Vein360 LLC

Intravascular ultrasound imaging catheter, reprocessed

• Primary Device ID: 00860036000517
• NIH Device Record Key: 043a0894-d2d8-4ca6-90c6-0d47bf84d44e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)
• Version Model Number: VEN-PV-014R
• Catalog Number: VEN-PV-014R
• 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	00860036000517 [Primary]

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: 2024-04-02
• Device Publish Date: 2024-03-25

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