PIVO 20G 000-0010

GUDID 10850984007000

PIVO 20G compatible device. Formerly TIVA.

VELANO VASCULAR, INC.

Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous

• Primary Device ID: 10850984007000
• NIH Device Record Key: c93c90c7-739d-49e6-9403-18979baed04c
• Commercial Distribution Discontinuation: 2018-07-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PIVO 20G
• Version Model Number: 000-0010
• Catalog Number: 000-0010
• Company DUNS: 079714011
• Company Name: VELANO VASCULAR, INC.
• 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: false
• 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

Customer Support Contacts

• Phone: 844 835 2668
• Email: arthur.long@velanovascular.com
• Phone: 844 835 2668
• Email: arthur.long@velanovascular.com
• Phone: 844 835 2668
• Email: arthur.long@velanovascular.com
• Phone: 844 835 2668
• Email: arthur.long@velanovascular.com
• Phone: 844 835 2668
• Email: arthur.long@velanovascular.com
• Phone: 844 835 2668
• Email: arthur.long@velanovascular.com
• Phone: 844 835 2668
• Email: arthur.long@velanovascular.com
• Phone: 844 835 2668
• Email: arthur.long@velanovascular.com
• Phone: 844 835 2668
• Email: arthur.long@velanovascular.com
• Phone: 844 835 2668
• Email: arthur.long@velanovascular.com
• Phone: 844 835 2668
• Email: arthur.long@velanovascular.com
• Phone: 844 835 2668
• Email: arthur.long@velanovascular.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850984007003 [Primary]
GS1	10850984007000 [Package]; Contains: 00850984007003; Package: Inner Pack [50 Units]; Discontinued: 2018-07-01; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142946

FDA Product Code

• JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-12
• Device Publish Date: 2017-01-03

On-Brand Devices [PIVO 20G]

• 00850984007027: PIVO (2.0) 20G compatible device.
• 10850984007000: PIVO 20G compatible device. Formerly TIVA.