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SPU 6leadAAMI cable

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 989803197511Model Single Patient Use Disposable "Sparrow"

by Philips Medizin Systeme Böblingen GmbH

Identity

Trade Name
SPU 6leadAAMI cable EUDAMED
Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets FDA UDI
Generic Name
Electrocardiographic lead set, single-use FDA UDI
Device Name
Single Patient Use Disposable "Sparrow" EUDAMED
6-Lead Set, disposable, for single patient use, to measure bedside ECG. AAMI color coded grabbers. Round (rd) peelable ribbon style wires. Wire length: 3,3ft (1m). For use with trunk cables: M1665A and M1667A. 1 Sales Unit = 20 single wrapped lead sets FDA UDI
Model / Reference
Single Patient Use Disposable "Sparrow" EUDAMED
989803197511 EUDAMED
SPU 6leadAAMI cable FDA UDI
Description
6-Lead Set, disposable, for single patient use, to measure bedside ECG. AAMI color coded grabbers. Round (rd) peelable ribbon style wires. Wire length: 3,3ft (1m). For use with trunk cables: M1665A and M1667A. 1 Sales Unit = 20 single wrapped lead sets FDA UDI

Identifiers

Catalog Number
989803197511 FDA UDI
Primary DI / UDI-DI
20884838114023 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM1101LG EUDAMED
Unit of Use DI
00884838114029 EUDAMED
FDA Product Code
DSA FDA UDI
EMDN Code
Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
GMDN Term
Electrocardiographic lead set, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
870.2900 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

No

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

SPU 6leadAAMI cable by Philips Medizin Systeme Böblingen GmbH — 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 Medizin Systeme Böblingen GmbH
EUDAMED SRN
DE-MF-000006026

Sources (2)

  • EUDAMED a7290cde-a57f-4928-9fb0-5fbc06a64a2d 61 fields · synced Jul 9, 2026
  • FDA UDI e9aa84c8-0ae8-4173-89c9-1f0092d35d5d 35 fields · synced May 30, 2026