Paradise® Catheter PRDS-068-02

GUDID 00810008950043

PRDS-068-02 Paradise® Catheter 8mm

Recor Medical, Inc.

Renal denervation ultrasound system catheter
Primary Device ID00810008950043
NIH Device Record Key920913bf-e5d8-4369-b76e-7d365106eb2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameParadise® Catheter
Version Model NumberPRDS-068-02
Catalog NumberPRDS-068-02
Company DUNS943549670
Company NameRecor Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
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

Device Dimensions

Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter
Balloon Diameter8 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100810008950043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QYIAblation Catheter, Renal Denervation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

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

On-Brand Devices [Paradise® Catheter]

00810008950067PRDS-063-02 Paradise® Catheter 3.5mm
00810008950043PRDS-068-02 Paradise® Catheter 8mm
00810008950036PRDS-067-02 Paradise® Catheter 7mm
00810008950005PRDS-064-02 Paradise® Catheter 4.2mm

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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