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OR 3-Lead ECG Trunk Cable, AAMI/IEC

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 989803170171

by Philips Medizin Systeme Böblingen GmbH

Identity

Trade Name
OR 3-Lead ECG Trunk Cable, AAMI/IEC EUDAMED
ECG Cables and Leadsets FDA UDI
Generic Name
Electrocardiographic lead set, reusable FDA UDI
Device Name
ECG Trunk Cables EUDAMED
OR 3-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code system AAMI and IEC. 1 trunk cable per bag. Cable length = 2,7 m (9ft). Use with indicated 3-lead products FDA UDI
Model / Reference
989803170171 EUDAMED
OR 3-Lead ECG Trunk Cable, AAMI/IEC FDA UDI
Description
OR 3-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code system AAMI and IEC. 1 trunk cable per bag. Cable length = 2,7 m (9ft). Use with indicated 3-lead products FDA UDI

Identifiers

Catalog Number
989803170171 FDA UDI
Primary DI / UDI-DI
00884838123328 EUDAMED
00884838012479 FDA UDI
Basic UDI-DI
0884838BM557TG EUDAMED
FDA Product Code
DPS FDA UDI
EMDN Code
Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
870.2340 FDA UDI
Market of Registration
Austria EUDAMED
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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

OR 3-Lead ECG Trunk Cable, AAMI/IEC by Philips Medizin Systeme Böblingen GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Medizin Systeme Böblingen GmbH
EUDAMED SRN
DE-MF-000006026

Sources (2)

  • EUDAMED 027ad688-7046-4160-8570-75582ab18772 61 fields · synced Jul 10, 2026
  • FDA UDI 3d2f48cd-a201-4b70-8e8b-d4526b2dafb2 36 fields · synced May 30, 2026