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RenewTM NCP-5 External Counterpulsation System

FDA UDI

Class II (US FDA UDI)

by Renew Group Private Limited

Identity

Trade Name
RenewTM NCP-5 External Counterpulsation System FDA UDI
Generic Name
External counterpulsation system, mobile FDA UDI
Device Name
EXTERNAL COUNTERPULSATION SYSTEM FDA UDI
Model / Reference
NCP-5 FDA UDI
Description
EXTERNAL COUNTERPULSATION SYSTEM FDA UDI

Identifiers

Catalog Number
21944 FDA UDI
Primary DI / UDI-DI
08883000001640 FDA UDI
510(k) Number
K152115 FDA UDI
FDA Product Code
DRN FDA UDI
GMDN Term
External counterpulsation system, mobile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5225 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: External counterpulsation system, mobile

RenewTM NCP-5 External Counterpulsation System by Renew Group Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External counterpulsation system, mobile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Renew Group Private Limited

Sources (1)

  • FDA UDI e70269c2-d9b9-4bf1-8d28-3ae840bfaca4 37 fields · synced May 31, 2026