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3 lead set, Disposable, Bedside, AAMI
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803173121Model Single Patient Use Disposable "Sparrow"
Identity
- Trade Name
- 3 lead set, Disposable, Bedside, AAMI EUDAMEDSingle-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" EUDAMED3-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: M1668A,M1669A, 1 Sales Unit = 20 single wrapped lead sets FDA UDI
- Model / Reference
- Single Patient Use Disposable "Sparrow" EUDAMED989803173121 EUDAMED3 lead set, Disposable, Bedside, AAMI FDA UDI
- Description
- 3-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: M1668A,M1669A, 1 Sales Unit = 20 single wrapped lead sets FDA UDI
Identifiers
- Catalog Number
- 989803173121 FDA UDI
- Primary DI / UDI-DI
- 20884838113972 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1101LG EUDAMED
- Unit of Use DI
- 00884838113978 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 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
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
MR Unsafe FDA UDI
3 lead set, Disposable, Bedside, AAMI 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM1101LG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED 08cf2f02-c443-4d07-b7dc-70a318c15ed1 61 fields · synced Jul 14, 2026
- FDA UDI 2489a28e-0874-4be7-a82b-5b597baac0a2 35 fields · synced May 25, 2026