Paradise® Remote PRDS-RM

GUDID 00810008950098

PRDS-RM Paradise® Remote

Recor Medical, Inc.

Renal denervation ultrasound system generator
Primary Device ID00810008950098
NIH Device Record Key642f1d11-a5ba-48e9-aa51-138f65b4f40c
Commercial Distribution StatusIn Commercial Distribution
Brand NameParadise® Remote
Version Model NumberPRDS-RM
Catalog NumberPRDS-RM
Company DUNS943549670
Company NameRecor Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com
Phone+16505427700
Emailregulatoryaffairs@recormedical.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100810008950098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QYIAblation Catheter, Renal Denervation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-19
Device Publish Date2023-12-11

Devices Manufactured by Recor Medical, Inc.

00810008950005 - Paradise® Catheter2023-12-19 PRDS-064-02 Paradise® Catheter 4.2mm
00810008950012 - Paradise® Catheter 2023-12-19 PRDS-065-02 Paradise® Catheter 5mm
00810008950029 - Paradise® Catheter 2023-12-19 PRDS-066-02 Paradise® Catheter 6mm
00810008950036 - Paradise® Catheter2023-12-19 PRDS-067-02 Paradise® Catheter 7mm
00810008950043 - Paradise® Catheter2023-12-19 PRDS-068-02 Paradise® Catheter 8mm
00810008950050 - Paradise® Connection Cable2023-12-19 PRDS-CC-02 Paradise® Connection Cable
00810008950067 - Paradise® Catheter2023-12-19 PRDS-063-02 Paradise® Catheter 3.5mm
00810008950074 - Paradise® Cartridge2023-12-19 PRDS-CT-02 Paradise® Cartridge

Trademark Results [Paradise]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PARADISE
PARADISE
98620325 not registered Live/Pending
Chakari, Zamary
2024-06-26
PARADISE
PARADISE
98458014 not registered Live/Pending
Australian Gold, LLC
2024-03-20
PARADISE
PARADISE
97913211 not registered Live/Pending
Han, Paul
2023-04-28
PARADISE
PARADISE
97867631 not registered Live/Pending
Eric West LLC
2023-03-31
PARADISE
PARADISE
97121904 not registered Live/Pending
Dakota Live!, LLC
2021-11-12
PARADISE
PARADISE
90979676 not registered Live/Pending
ReCor Medical, Inc.
2021-01-14
PARADISE
PARADISE
90654570 not registered Live/Pending
Emily's Foods, LLC
2021-04-19
PARADISE
PARADISE
90644927 not registered Live/Pending
Glover, Jalan
2021-04-14
PARADISE
PARADISE
90644927 not registered Live/Pending
LaFrance, Antoine
2021-04-14
PARADISE
PARADISE
90600537 not registered Live/Pending
Beaty, Grant
2021-03-24
PARADISE
PARADISE
90542299 not registered Live/Pending
Business International Group
2021-02-23
PARADISE
PARADISE
90465900 not registered Live/Pending
ReCor Medical, Inc.
2021-01-14

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