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

GUDID 00860036000579

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

Vein360 LLC

Intravascular ultrasound imaging catheter, reprocessed

• Primary Device ID: 00860036000579
• NIH Device Record Key: a348c1de-901b-469a-ab9f-4436dc76578b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P)
• Version Model Number: VEN-PV-014P
• Catalog Number: VEN-PV-014P
• 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	00860036000579 [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 Digitial IVUS Catheter (014P)]

• 00860036000579: Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P)
• 00850065047034: Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P) for Medline Renewal