Paradise® Connection Cable

Primary DI
00810008950050
Brand
Paradise® Connection Cable
Company
Recor Medical, Inc.
Model
PRDS-CC-02
Catalog number
PRDS-CC-02
Device description
PRDS-CC-02 Paradise® Connection Cable
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00810008950050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810008950050008100089500508100089500500810008950050

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-18 Degrees Celsius55 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-18 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
943549670
Device count
1
Lot or batch
true
Expiration 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
00810008950074Paradise® CartridgePRDS-CT-02PRDS-CT-022023-12-11
00810008950098Paradise® RemotePRDS-RMPRDS-RM2023-12-11
00810008950111Paradise® GeneratorPRDS-USG-2XPRDS-USG-2X2023-12-11
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
00810008950067Paradise® CatheterRecor Medical, Inc.QYI2023-12-11
00810008950074Paradise® CartridgeRecor Medical, Inc.QYI2023-12-11
00810008950098Paradise® RemoteRecor Medical, Inc.QYI2023-12-11
00810008950111Paradise® GeneratorRecor 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