Paradise® Catheter PRDS-068-02

GUDID 00810008950043

PRDS-068-02 Paradise® Catheter 8mm

Recor Medical, Inc.

Renal denervation ultrasound system catheter

• Primary Device ID: 00810008950043
• NIH Device Record Key: 920913bf-e5d8-4369-b76e-7d365106eb2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paradise® Catheter
• Version Model Number: PRDS-068-02
• Catalog Number: PRDS-068-02
• Company DUNS: 943549670
• Company Name: Recor Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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

Device Dimensions

• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter
• Balloon Diameter: 8 Millimeter

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	00810008950043 [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: 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

On-Brand Devices [Paradise® Catheter]

• 00810008950067: PRDS-063-02 Paradise® Catheter 3.5mm
• 00810008950043: PRDS-068-02 Paradise® Catheter 8mm
• 00810008950036: PRDS-067-02 Paradise® Catheter 7mm
• 00810008950005: PRDS-064-02 Paradise® Catheter 4.2mm