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5 Leads Set Disposable, Bedside Iec Rd
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803174211
Identity
- Trade Name
- 5 LEADS SET DISPOSABLE, BEDSIDE IEC RD EUDAMEDECG Electrodes FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- ECG lead wire EUDAMEDPhilips Single-Patient-Use Disposable ECG Lead Sets are intended for use only by trained healthcare professionals for measurement of a patients ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. These Philips lead sets are intended for short-term use only (average patient stay of 5 days). Average lifetime of 5 days for disposable products. FDA UDI
- Model / Reference
- 989803174211 EUDAMED5 LEADS SET DISPOSABLE, BEDSIDE IEC RD FDA UDI
- Description
- Philips Single-Patient-Use Disposable ECG Lead Sets are intended for use only by trained healthcare professionals for measurement of a patients ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. These Philips lead sets are intended for short-term use only (average patient stay of 5 days). Average lifetime of 5 days for disposable products. FDA UDI
Identifiers
- Catalog Number
- 989803174211 FDA UDI
- Primary DI / UDI-DI
- 20884838075737 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM343ST EUDAMED
- Unit of Use DI
- 00884838075733 EUDAMED
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass 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
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
MR Unsafe FDA UDI
5 Leads Set Disposable, Bedside Iec Rd 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM343ST | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 c98496ed-85bb-4f18-bb70-3d7070511960 61 fields · synced Jun 18, 2026
- FDA UDI 45c22d59-4b16-4bee-ab70-b20d7c74bcba 36 fields · synced May 30, 2026