FDA.reportPublic FDA data

RenewTM NCP-5 External Counterpulsation System

Primary DI
00865089000316
Brand
RenewTM NCP-5 External Counterpulsation System
Company
S2 Equipment LLC
Model
NCP-5
Published
2018-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRNDevice, Counter-Pulsating, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRNDevice, Counter-Pulsating, ExternalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865089000316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865089000316008650890003168650890003160865089000316

GMDN Terms#

Term, Definition table
TermDefinition
External counterpulsation system, mobileA noninvasive, mobile assembly of devices intended to assist the blood circulation of an adult patient suffering from heart disease through the electrocardiogram (ECG) synchronized inflation of pressure cuffs worn around the extremities/buttocks. It includes an air pump with inflatable cuffs, ECG cables, a control unit or software for use with a personal computer (PC), and may include a pulse oximeter probe. The cuffs are intended to inflate from the most distal to the most proximal during diastole and deflate during systole to increase preload/decrease afterload. The system is intended to be operated by a professional in a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure45 KiloPascal105 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-15 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
248-987-7848customerfeedback@renewecpusa.com

Regulatory Flags#

DUNS number
084717183
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979448890020HuawenVamed Medical Instrument Co.,LtdDRN2026-04-17
06971379470067PSK, Air-bag Type Sequential External Counter-pulsation DeviceChongqing PSK-Health Sci-Tech Development Co.,Ltd.DRN2025-04-15
06971379470074PSK, Air-bag Type Sequential External Counter-pulsation DeviceChongqing PSK-Health Sci-Tech Development Co.,Ltd.DRN2025-04-15
06975435800058OmayOmay(Guangzhou) Med Technologies Co.,LtdDRN2023-12-21
06971379470012ECP PSKChongqing PSK-Health Sci-Tech Development Co.,Ltd.DRN2017-12-04
06971379470029ECP PSKChongqing PSK-Health Sci-Tech Development Co.,Ltd.DRN2017-12-04
00868331000409RejuvaHeartNORTH AMERICAN ECP INC.DRN2017-10-17
08883000001640RenewTM NCP-5 External Counterpulsation System RENEW GROUP PRIVATE LIMITEDDRN2017-03-15
00817980020740Vasomedical™ AngioNew -V EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020757Vasomedical™ AngioNew -V EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020764Vasomedical™ AngioNew -VI EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020771Vasomedical™ AngioNew -VI EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020788Vasomedical™Lumenair™ EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020795Vasomedical™Lumenair™ EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020801Vasomedical™ TS-4 EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020818Vasomedical™ TS-4EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020825Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™)VASOMEDICAL, INC.DRN2016-11-29
00817980020832Roll ECG Paper, 240 ft. (Model MC2)VASOMEDICAL, INC.DRN2016-11-29
00817980020849Nu Prep Gel, 4 oz (3 PK)VASOMEDICAL, INC.DRN2016-11-29
00817980020856Signa Electrode Gel, 8 ozVASOMEDICAL, INC.DRN2016-11-29
00817980020863Signa Electrode Gel, 2 ozVASOMEDICAL, INC.DRN2016-11-29
008179800208703 Lead Integrated ECG Cable (AngioNew® V & VI)VASOMEDICAL, INC.DRN2016-11-29
008179800208873 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™)VASOMEDICAL, INC.DRN2016-11-29
008179800208943 Lead Integrated ECG Cable with adapter (Model TS3)VASOMEDICAL, INC.DRN2016-11-29
00817980020900ECG Cable Adaptor-for use with V10-0017 (Model TS3)VASOMEDICAL, INC.DRN2016-11-29
00817980020917Electrodes (600 per case)VASOMEDICAL, INC.DRN2016-11-29
00817980020924Cuff Set, X-SmallVASOMEDICAL, INC.DRN2016-11-29
00817980020931Cuff Set, SmallVASOMEDICAL, INC.DRN2016-11-29
00817980020948Cuff Set, MediumVASOMEDICAL, INC.DRN2016-11-29
00817980020955Cuff Set, LargeVASOMEDICAL, INC.DRN2016-11-29