Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable IVLGCCDX

GUDID 00195451000355

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.

Intravascular lithotripsy system generator

• Primary Device ID: 00195451000355
• NIH Device Record Key: 5c297e9e-f83c-49d1-b1a4-44d5e4939e82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable
• Version Model Number: 825Dx
• Catalog Number: IVLGCCDX
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195451000355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221041

FDA Product Code

• PPN: Percutaneous Catheter, Ultrasound

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-05
• Device Publish Date: 2022-12-22

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