RejuvaHeart

FDA UDI

Class II (US FDA UDI)

by North American Ecp Inc.

Identity

Trade Name: RejuvaHeart FDA UDI
Generic Name: External counterpulsation system, stationary FDA UDI
Device Name: External Counter Pulsation Device FDA UDI
Model / Reference: NCP-2 FDA UDI
Description: External Counter Pulsation Device FDA UDI

Identifiers

Catalog Number: No FDA UDI
Primary DI / UDI-DI: 00868331000409 FDA UDI
FDA Product Code: DRN FDA UDI
GMDN Term: External counterpulsation system, stationary 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 29 Inch FDA UDI
Length — 80 Inch FDA UDI
Width — 35.25 Inch FDA UDI
Width — 30 Inch FDA UDI
Height — 66.5 Inch FDA UDI
Length — 18.5 Inch FDA UDI

Category: External counterpulsation system, stationary

RejuvaHeart by North American Ecp Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External counterpulsation system, stationary.

Bladder Set, Medium — VASOMEDICAL, INC. · Class II
AnKle Strap — VASOMEDICAL, INC. · Class II
Bladder Set, Small — VASOMEDICAL, INC. · Class II
Thigh Cuff, X-Large — VASOMEDICAL, INC. · Class II
Patient Stop Cable (Model TS4 and Lumenair™) — VASOMEDICAL, INC. · Class II
Calf Cuff, X-Large — VASOMEDICAL, INC. · Class II
Hose Single, (300mm) (AngioNew® VI) — VASOMEDICAL, INC. · Class II
TwiLoK™ Cuff Side Hose Connector — VASOMEDICAL, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: North American Ecp Inc.

Sources (1)

FDA UDI 527acb10-733c-454e-88af-3df5a17871b7 36 fields · synced May 31, 2026