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nGEN Generator D138402

FDA UDIEUDAMED

Class III (US FDA UDI)

Ref D138405Model nGEN Generator

by Biosense Webster Inc

Identity

Trade Name
nGEN EUDAMED
nGEN Generator FDA UDI
Generic Name
Cardiac radio-frequency ablation system generator FDA UDI
Device Name
nGEN Generator EUDAMED
Generator FDA UDI
Model / Reference
nGEN Generator EUDAMED
D138405 EUDAMED
D138402 FDA UDI
Description
Generator FDA UDI

Identifiers

Catalog Number
D138402 FDA UDI
Primary DI / UDI-DI
10846835033175 EUDAMED
10846835018080 FDA UDI
Basic UDI-DI
08468350a0007F3 EUDAMED
PMA Number
P010068 FDA UDI
P030031 FDA UDI
P040036 FDA UDI
P950005 FDA UDI
P990025 FDA UDI
P990071 FDA UDI
FDA Product Code
LPB FDA UDI
OAE FDA UDI
DRF FDA UDI
OAD FDA UDI
EMDN Code
Z12059011 CARDIAC ABLATION EQUIPMENT EUDAMED
GMDN Term
Cardiac radio-frequency ablation system generator FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class III FDA UDI
Regulation Number
870.1220 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Category: Cardiac radio-frequency ablation system generator

The nGEN Generator D138402 is a cardiac radio-frequency ablation system generator, designed to generate radio-frequency energy for creating ablative lesions in cardiac tissue during arrhythmia treatment. It includes control interfaces and may integrate with electrocardiograph (ECG) monitoring, supporting both endocardial ablation via percutaneous catheters and epicardial ablation with electrode probes.

This reusable, non-sterile device is intended for use in clinical settings requiring prescription authorization and is classified under EU MDR. It requires special storage conditions, including protection from moisture and direct sunlight, and is supplied with a single-unit package. The device lacks an expiration date but includes manufacturing and serial number markings for traceability. MRI safety information is not provided for this model.

Similar devices

Also classified as Cardiac radio-frequency ablation system generator.

Cleared under the same submission

P010068 also covers:

P030031 also covers:

P040036 also covers:

P950005 also covers:

P990025 also covers:

P990071 also covers:

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: nGEN™ Generator | J&J MedTech US - Johnson & Johnson Medical Devices, nGEN™ Generator for Ablation Systems | PDF - Scribd, CARTO™ System, Hardware | J&J MedTech US - Johnson & Johnson Medical ..., TRUPULSE Generator; Sterile Interface Cable; nGEN Pump ... - FDA

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biosense Webster Inc

Sources (2)

  • FDA UDI 7bf94063-b51e-42ac-80ea-c024d889d3e1 37 fields · synced Sep 18, 2026
  • EUDAMED 5f3e9dca-0757-494e-860d-6f90f8a6cc78 61 fields · synced Jul 22, 2026