Paradise® Cartridge PRDS-CT-02

GUDID 00810008950074

PRDS-CT-02 Paradise® Cartridge

Recor Medical, Inc.

Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber Renal denervation ultrasound system cooling solution flow chamber

• Primary Device ID: 00810008950074
• NIH Device Record Key: 327160e4-f5fe-4ba1-833b-5c38c671720f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paradise® Cartridge
• Version Model Number: PRDS-CT-02
• Catalog Number: PRDS-CT-02
• 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: 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: +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 -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008950074 [Primary]
GS1	10810008950071 [Package]; Package: [5 Units]; In Commercial Distribution

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: true

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

Devices Manufactured by Recor Medical, Inc.

• 00810008950005 - Paradise® Catheter: 2023-12-19 PRDS-064-02 Paradise® Catheter 4.2mm
• 00810008950012 - Paradise® Catheter: 2023-12-19 PRDS-065-02 Paradise® Catheter 5mm
• 00810008950029 - Paradise® Catheter: 2023-12-19 PRDS-066-02 Paradise® Catheter 6mm
• 00810008950036 - Paradise® Catheter: 2023-12-19 PRDS-067-02 Paradise® Catheter 7mm
• 00810008950043 - Paradise® Catheter: 2023-12-19 PRDS-068-02 Paradise® Catheter 8mm
• 00810008950050 - Paradise® Connection Cable: 2023-12-19 PRDS-CC-02 Paradise® Connection Cable
• 00810008950067 - Paradise® Catheter: 2023-12-19 PRDS-063-02 Paradise® Catheter 3.5mm
• 00810008950074 - Paradise® Cartridge: 2023-12-19PRDS-CT-02 Paradise® Cartridge
• 00810008950074 - Paradise® Cartridge: 2023-12-19 PRDS-CT-02 Paradise® Cartridge