Reprocessed Visions PV.035 Digital IVUS Catheter VEN-PV-035

GUDID 00860036000531

Reprocessed Visions PV.035 Digital IVUS Catheter

Vein360 LLC

Intravascular ultrasound imaging catheter, reprocessed

• Primary Device ID: 00860036000531
• NIH Device Record Key: 3e475995-36ae-49a0-a341-c628c74e4a48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed Visions PV.035 Digital IVUS Catheter
• Version Model Number: VEN-PV-035
• Catalog Number: VEN-PV-035
• 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	00860036000531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230584

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: 2023-09-06
• Device Publish Date: 2023-08-29

Devices Manufactured by Vein360 LLC

• 00850065047003 - Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R): 2024-08-12 Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R) for Medline Renewal
• 00850065047010 - Vein360 Reprocessed Digital Intravascular (IVUS) Reprocessed Catheter PV .018: 2024-08-12 Vein360 Reprocessed Digital Intravascular (IVUS) Reprocessed Catheter PV .018 for Medline Renewal
• 00850065047027 - Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter: 2024-08-12 Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter for Medline Renewal
• 00850065047034 - Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P): 2024-08-12 Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P) for Medline Renewal
• 00850065047041 - Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter: 2024-08-12 Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter for Medline Renewal
• 00850065047058 - Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter: 2024-08-12 Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter for Medline Renewal
• 00860036000517 - Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R): 2024-04-02 Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)
• 00860036000579 - Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P): 2024-04-02 Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P)