Guardian® II hemostasis valve

GUDID M20682110

The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67mm) during diagnostic/interventional procedures. The torque device is provided as an aid for steering the guidewire within the vascular anatomy.

Vascular Solutions, Inc.

Haemostasis valve

• Primary Device ID: M20682110
• NIH Device Record Key: 6c5dbe61-2bdf-44da-aa3d-762fbeaa4122
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian® II hemostasis valve
• Version Model Number: 8211
• Company DUNS: 008999906
• Company Name: Vascular Solutions, 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: true
• 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: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M20682110 [Primary]
HIBCC	M20682111 [Package]; Package: Box [25 Units]; In Commercial Distribution

FDA Product Code

• DTL: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-05
• Device Publish Date: 2016-09-06

On-Brand Devices [Guardian® II hemostasis valve]

• M20682110: The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic
• M20682101: The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic