LAVA Mixing Kit, 6 mL

GUDID 00850055697058

LAVA Mixing Kit, 6 mL (to homogenize the liquid embolic suspension)

Blackswan Vascular, Inc.

Embolization particle, non-bioabsorbable

• Primary Device ID: 00850055697058
• NIH Device Record Key: 7358a1a9-e8b5-445d-b33e-49d1de6a7d57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LAVA Mixing Kit, 6 mL
• Version Model Number: SLLESMK6
• Company DUNS: 111242823
• Company Name: Blackswan Vascular, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com
• Phone: 1-888-474-7839
• Email: csusa@sirtex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850055697058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P220020
• Premarket Approval: P220020

FDA Product Code

• QVG: Embolization Agent, Vascular

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: 2023-10-31
• Device Publish Date: 2023-10-23

Devices Manufactured by Blackswan Vascular, Inc.

• 00850055697003 - LAVA-18, 2 mL: 2023-10-31 LAVA Liquid Embolic System (LES) Kit, LAVA-18, 2 mL
• 00850055697010 - LAVA-34, 2 mL: 2023-10-31 LAVA Liquid Embolic System (LES) Kit, LAVA-34, 2 mL
• 00850055697027 - LAVA-18, 6 mL: 2023-10-31 LAVA Liquid Embolic System (LES) Kit, LAVA-18, 6 mL
• 00850055697034 - LAVA-34, 6 mL: 2023-10-31 LAVA Liquid Embolic System (LES) Kit, LAVA-34, 6 mL
• 00850055697041 - LAVA Mixing Kit, 2 mL: 2023-10-31 LAVA Mixing Kit, 2 mL (to homogenize the liquid embolic suspension)
• 00850055697058 - LAVA Mixing Kit, 6 mL: 2023-10-31LAVA Mixing Kit, 6 mL (to homogenize the liquid embolic suspension)
• 00850055697058 - LAVA Mixing Kit, 6 mL: 2023-10-31 LAVA Mixing Kit, 6 mL (to homogenize the liquid embolic suspension)