Vitale VITB08

GUDID 00853892004119

Occlusion Balloon Catheter, 8F compatible

QXMEDICAL

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00853892004119
• NIH Device Record Key: ef24f08b-dfa0-4591-993c-dc1886fe861b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitale
• Version Model Number: VITB08
• Catalog Number: VITB08
• Company DUNS: 022672652
• Company Name: QXMEDICAL
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com
• Phone: 651-842-2050
• Email: admin@qxmedical.com

Device Dimensions

• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French
• Balloon Length: 80 Millimeter
• Catheter Length: 90 Centimeter
• Crossing Profile: 8 French
• Introducer Sheath Compatibilit: 8 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853892004119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183679

FDA Product Code

• MJN: Catheter, Intravascular Occluding, Temporary

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: 2019-06-03
• Device Publish Date: 2019-05-24

On-Brand Devices [Vitale]

• 00853892004126: Occlusion Balloon Catheter, 10F compatible
• 00853892004119: Occlusion Balloon Catheter, 8F compatible