AccessGUDID - DEVICE: Paradise® Catheter (00810008950029)

GUDID

Device Identifier (DI) Information

Brand Name: Paradise® Catheter
Version or Model: PRDS-066-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRDS-066-02
Company Name: Recor Medical, Inc.

Primary DI Number: 00810008950029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 943549670 *Terms of Use

Device Description: PRDS-066-02 Paradise® Catheter 6mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
65657	Renal denervation ultrasound system catheter	An electrically-powered, steerable, thin, flexible tube intended to be introduced percutaneously into the renal artery to emit ultrasound energy, with simultaneous arterial wall cooling to prevent arterial wall damage, for renal denervation (RDN). It includes a distal ultrasound transducer and balloon for the circulation of cooling fluids. 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
Balloon Diameter: 6 Millimeter

Device Record Status

Public Device Record Key: b9a7a088-6496-4924-b173-cdd8cc685ed6
Public Version Date: December 19, 2023
Public Version Number: 1
DI Record Publish Date: December 11, 2023