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Preattached Square Leadwire Electrode

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 13953E

by Philips Medical Systems

Identity

Trade Name
PREATTACHED SQUARE LEADWIRE ELECTRODE EUDAMED
ECG Cables and Leadsets FDA UDI
Generic Name
Electrocardiographic electrode, single-use FDA UDI
Device Name
Electrocardiographic Electrodes Cardinal EUDAMED
Preattached Square leadwire electrode Radiolucent carbon IEC color 45cm/18" leadwires with 1.5mm/.060" safety socket square 22cm x 22cm cloth backing with Ag/AgCl sensor, 3/pouch, 300/case. FDA UDI
Model / Reference
13953E EUDAMED
PREATTACHED SQUARE LEADWIRE ELECTRODE FDA UDI
Description
Preattached Square leadwire electrode Radiolucent carbon IEC color 45cm/18" leadwires with 1.5mm/.060" safety socket square 22cm x 22cm cloth backing with Ag/AgCl sensor, 3/pouch, 300/case. FDA UDI

Identifiers

Catalog Number
13953E FDA UDI
Primary DI / UDI-DI
20884838000906 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM532SY EUDAMED
Unit of Use DI
10884838000909 EUDAMED
FDA Product Code
DRX FDA UDI
EMDN Code
Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
GMDN Term
Electrocardiographic electrode, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
870.2360 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

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

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Preattached Square Leadwire Electrode by Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Medical Systems
EUDAMED SRN
US-MF-000002321
Authorised Representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Sources (2)

  • EUDAMED cd1d23f7-c0b9-43f0-8b35-086628dcc327 61 fields · synced Aug 2, 2026
  • FDA UDI 1fcd4680-fa72-41c9-b4a5-3acec3e6481f 35 fields · synced May 30, 2026