Simon Nitinol Filter™ 3320A

GUDID 00801741109218

Simon Nitinol Filter™ , Vena Cava Filter, Anticubital Introducer Set

Bard Peripheral Vascular, Inc.

Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent

• Primary Device ID: 00801741109218
• NIH Device Record Key: d2a42e0d-f480-4c8c-8319-c24228feed8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simon Nitinol Filter™
• Version Model Number: 3320A
• Catalog Number: 3320A
• Company DUNS: 135057938
• Company Name: Bard Peripheral Vascular, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com

Device Dimensions

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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741109218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970099

FDA Product Code

• DTK: FILTER, INTRAVASCULAR, CARDIOVASCULAR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-02

On-Brand Devices [Simon Nitinol Filter™]

• 00801741109218: Simon Nitinol Filter™ , Vena Cava Filter, Anticubital Introducer Set
• 00801741109195: Simon Nitinol Filter™ , Vena Cava Filter, Jugular Introducer Set
• 00801741109188: Simon Nitinol Filter™ , Vena Cava Filter, Femoral Introducer Set
• 00801741040924: Simon Nitinol Filter™ Antecubital Filter Set
• 00801741040917: Simon Nitinol Filter™ Jugular/Subclavian Delivery Set
• 00801741040900: Simon Nitinol Filter™ Femoral Delivery Set