FDA.reportPublic FDA data

Paradise® Generator

Primary DI
00810008950111
Brand
Paradise® Generator
Company
Recor Medical, Inc.
Model
PRDS-USG-2X
Catalog number
PRDS-USG-2X
Device description
PRDS-USG-2X Paradise® Generator
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QYIAblation Catheter, Renal Denervation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYIAblation Catheter, Renal DenervationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220023000Paradise® Ultrasound Renal Denervation SystemRecor Medical, Inc.2023-11-07QYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810008950111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810008950111008100089501118100089501110810008950111

GMDN Terms#

Term, Definition table
TermDefinition
Renal denervation ultrasound system generatorAn electrically-powered component of an ultrasound renal denervation system intended to: 1) generate a high frequency electrical current for subsequent conversion to ultrasound energy by a system catheter (not included); and 2) control the flow of cooling solution (e.g., sterile water) intended to prevent arterial wall damage, during renal denervation (RDN).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius65 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+16505427700RegulatoryAffairs@recormedical.com

Regulatory Flags#

DUNS number
943549670
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810008950005Paradise® CatheterPRDS-064-02PRDS-064-022023-12-11
00810008950012Paradise® Catheter PRDS-065-02PRDS-065-022023-12-11
00810008950029Paradise® Catheter PRDS-066-02PRDS-066-022023-12-11
00810008950036Paradise® CatheterPRDS-067-02PRDS-067-022023-12-11
00810008950043Paradise® CatheterPRDS-068-02PRDS-068-022023-12-11
00810008950067Paradise® CatheterPRDS-063-02PRDS-063-022023-12-11
00810008950104Paradise® CartPRDS-CRTPRDS-CRT2024-01-10
00810008950050Paradise® Connection CablePRDS-CC-02PRDS-CC-022023-12-11
00810008950074Paradise® CartridgePRDS-CT-02PRDS-CT-022023-12-11
00810008950098Paradise® RemotePRDS-RMPRDS-RM2023-12-11
00810008950128Paradise® GeneratorPRDS-USG-2XPRDS-USG-2X2023-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810008950005Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950012Paradise® Catheter Recor Medical, Inc.QYI2023-12-11
00810008950029Paradise® Catheter Recor Medical, Inc.QYI2023-12-11
00810008950036Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950043Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950050Paradise® Connection CableRecor Medical, Inc.QYI2023-12-11
00810008950067Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950074Paradise® CartridgeRecor Medical, Inc.QYI2023-12-11
00810008950098Paradise® RemoteRecor Medical, Inc.QYI2023-12-11
00810008950128Paradise® GeneratorRecor Medical, Inc.QYI2023-12-11
00763000354466Symplicity Spyral™MEDTRONIC, INC.QYI2023-11-30
00763000387020Symplicity G3™MEDTRONIC, INC.QYI2023-11-30