Ellipse™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: Ellipse™ FDA UDI
Generic Name: Dual-chamber implantable defibrillator FDA UDI
Device Name: Tiered-therapy cardioverter/defibrillator VVEV VVIR FDA UDI
Model / Reference: CD2311-36Q FDA UDI
Description: Tiered-therapy cardioverter/defibrillator VVEV VVIR FDA UDI

Identifiers

Catalog Number: CD2311-36Q FDA UDI
Primary DI / UDI-DI: 05414734505994 FDA UDI
FDA Product Code: NVZ FDA UDI
GMDN Term: Dual-chamber implantable defibrillator FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Total Volume — 31.3 Milliliter FDA UDI

Category: Dual-chamber implantable defibrillator

Ellipse™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dual-chamber implantable defibrillator.

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INOGEN™ EL ICD DR — Boston Scientific · Class III
Cobalt™ XT DR MRI SureScan™ — MEDTRONIC, INC. · Class III
INCEPTA™ CRT-D — Boston Scientific · Class III
Crome™ DR MRI SureScan™ — MEDTRONIC, INC. · Class III

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 III	Pending data

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Manufacturer

Manufacturer: St. Jude Medical, Inc.

Sources (1)

FDA UDI 146a93c0-0681-4781-88ab-720d1044e880 37 fields · synced May 31, 2026