AccessGUDID - DEVICE: Paradise® Cartridge (00810008950074)

GUDID

Device Identifier (DI) Information

Brand Name: Paradise® Cartridge
Version or Model: PRDS-CT-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRDS-CT-02
Company Name: Recor Medical, Inc.

Primary DI Number: 00810008950074
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 943549670 *Terms of Use

Device Description: PRDS-CT-02 Paradise® Cartridge

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QYI	Ablation Catheter, Renal Denervation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P220023	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -18 and 55 Degrees Celsius
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -18 and 55 Degrees Celsius
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 327160e4-f5fe-4ba1-833b-5c38c671720f
Public Version Date: December 19, 2023
Public Version Number: 1
DI Record Publish Date: December 11, 2023