Vein360 Reprocessed Digital Intravascular (IVUS) Reprocessed Catheter PV .018 86700RH

GUDID 00850065047010

Vein360 Reprocessed Digital Intravascular (IVUS) Reprocessed Catheter PV .018 for Medline Renewal

Vein360 LLC

Intravascular ultrasound imaging catheter, reprocessed

• Primary Device ID: 00850065047010
• NIH Device Record Key: ba947f54-cb68-4d23-bef7-9161c3810aa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vein360 Reprocessed Digital Intravascular (IVUS) Reprocessed Catheter PV .018
• Version Model Number: 86700RH
• Catalog Number: 86700RH
• 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	00850065047010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230928

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

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: 2024-08-12Vein360 Reprocessed Digital Intravascular (IVUS) Reprocessed Catheter PV .018 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)