Paradise® Catheter PRDS-064-02

GUDID 00810008950005

PRDS-064-02 Paradise® Catheter 4.2mm

Recor Medical, Inc.

Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter Renal denervation ultrasound system catheter

• Primary Device ID: 00810008950005
• NIH Device Record Key: b1a92d95-4b2c-4af5-a94d-c0a1795eeb2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paradise® Catheter
• Version Model Number: PRDS-064-02
• Catalog Number: PRDS-064-02
• 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: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 Millimeter
• Balloon Diameter: 4.2 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	00810008950005 [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