Paradise® Generator PRDS-USG-2X

GUDID 00810008950111

PRDS-USG-2X Paradise® Generator

Recor Medical, Inc.

Renal denervation ultrasound system generator

• Primary Device ID: 00810008950111
• NIH Device Record Key: 62395382-fae2-4713-b7ff-e435b39cccbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paradise® Generator
• Version Model Number: PRDS-USG-2X
• Catalog Number: PRDS-USG-2X
• Company DUNS: 943549670
• Company Name: Recor 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: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com
• Phone: +16505427700
• Email: RegulatoryAffairs@recormedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008950111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P220023

FDA Product Code

• QYI: Ablation Catheter, Renal Denervation

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: 2023-12-19
• Device Publish Date: 2023-12-11

On-Brand Devices [Paradise® Generator]

• 00810008950128: PRDS-USG-2X Paradise® Generator with Paradise® Remote
• 00810008950111: PRDS-USG-2X Paradise® Generator