Paradise® Cartridge

Basic Information

• Brand Name: Paradise® Cartridge
• Primary DI: 00810008950074
• Version / Model: PRDS-CT-02
• Catalog Number: PRDS-CT-02
• Company Name: Recor Medical, Inc.
• Labeler DUNS: 943549670
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-11
• Public Version: 1
• Public Version Date: 2023-12-19
• Public Version Status: New
• Public Device Record Key: 327160e4-f5fe-4ba1-833b-5c38c671720f

Device Description

PRDS-CT-02 Paradise® Cartridge

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QYI	Ablation Catheter, Renal Denervation	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
65658	Renal denervation ultrasound system cooling solution flow chamber	A component of an ultrasound renal denervation system designed to facilitate system generator-controlled flow of cooling solution (e.g., sterile water) to the system catheter during renal denervation (RDN). It includes tubing, electronic sensors and syringes, and is intended to receive power from, and send signals to, the generator. The flow of cooling fluid to the catheter tip is intended to prevent arterial wall damage during ultrasound denervation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810008950074	GS1
Package	10810008950071	GS1		5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P220023	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -18 – 55 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -18 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity