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Disp Metallic 3 Leadwire Elect Set, Aami
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803156201
Identity
- Trade Name
- DISP METALLIC 3 LEADWIRE ELECT SET, AAMI EUDAMEDECG Electrodes FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Electrocardiographic Electrodes EUDAMEDDisposable, adult, 3-lead ECG monitoring, solid gel electrodes with pre-attached 39 inch (100cm) non-shielded, copper, AAMI color-coded lead wires. Silver/silver chloride (Ag/AgCi) sensor, repositionable. Electrode is rectangular in shape and is 30 mm x 45 mm in size. Packaging is 1 set (3pcs.) per pouch or 100 sets (300 pcs) per box. Sold in box quantities only. For use with all adult ECG monitors; NOT for use with Philips Telemetry Transmitters and Transceivers. FDA UDI
- Model / Reference
- 989803156201 EUDAMEDDISP METALLIC 3 LEADWIRE ELECT SET, AAMI FDA UDI
- Description
- Disposable, adult, 3-lead ECG monitoring, solid gel electrodes with pre-attached 39 inch (100cm) non-shielded, copper, AAMI color-coded lead wires. Silver/silver chloride (Ag/AgCi) sensor, repositionable. Electrode is rectangular in shape and is 30 mm x 45 mm in size. Packaging is 1 set (3pcs.) per pouch or 100 sets (300 pcs) per box. Sold in box quantities only. For use with all adult ECG monitors; NOT for use with Philips Telemetry Transmitters and Transceivers. FDA UDI
Identifiers
- Catalog Number
- 989803156201 FDA UDI
- Primary DI / UDI-DI
- 20884838007868 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM340SM EUDAMED
- Unit of Use DI
- 10884838007861 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 EUDAMEDClass 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
Disp Metallic 3 Leadwire Elect Set, Aami 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 | 0884838BM340SM | 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 7249ff31-ca30-4fe6-a40a-18217ffa7132 61 fields · synced Jul 21, 2026
- FDA UDI 0a1ba208-5619-4e70-8ce5-2b01b6eaf729 36 fields · synced May 30, 2026