Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable IVLGCCDC

GUDID 00195451000461

The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic arteries.

Shockwave Medical, Inc.

Ultrasound thrombolysis system control unit

• Primary Device ID: 00195451000461
• NIH Device Record Key: 42cf1c05-ecbd-40e5-ba03-2827d246aea2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable
• Version Model Number: 825Dc
• Catalog Number: IVLGCCDC
• Company DUNS: 055514478
• Company Name: Shockwave Medical, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195451000461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191840

FDA Product Code

• PPN: Percutaneous Catheter, Ultrasound

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-13
• Device Publish Date: 2022-12-05

On-Brand Devices [Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable]

• 00195451000294: The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data v
• 00195451000461: The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data v
• 00195451000355: The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data v