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5-Lead Set, Disposable, Chest, Iec
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803192151Model Single Patient Use Disposable "Sparrow"
Identity
- Trade Name
- 5-LEAD SET, DISPOSABLE, CHEST, IEC 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" EUDAMED5-Lead Set, disposable chest leads for single patient use, to measure 12-lead bedside ECG.IEC color codedgrabbers. Round peelable ribbon style wires. Wire length: 3.3ft (1m). For use with trunk cables: M1663A and M1949A when paired with 989803174211 (disposable limb leads). 1 Sales Unit = 20 individually packaged lead sets. FDA UDI
- Model / Reference
- Single Patient Use Disposable "Sparrow" EUDAMED989803192151 EUDAMED5-LEAD SET, DISPOSABLE, CHEST, IEC FDA UDI
- Description
- 5-Lead Set, disposable chest leads for single patient use, to measure 12-lead bedside ECG.IEC color codedgrabbers. Round peelable ribbon style wires. Wire length: 3.3ft (1m). For use with trunk cables: M1663A and M1949A when paired with 989803174211 (disposable limb leads). 1 Sales Unit = 20 individually packaged lead sets. FDA UDI
Identifiers
- Catalog Number
- 989803192151 FDA UDI
- Primary DI / UDI-DI
- 20884838114085 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1101LG EUDAMED
- Unit of Use DI
- 00884838114081 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
5-Lead Set, Disposable, Chest, 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
| 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 5a4a4f9f-1e84-4fe0-9136-5def8bb53846 61 fields · synced Jun 18, 2026
- FDA UDI 81370e29-e4ec-4228-8cc4-246737c9a2de 35 fields · synced May 30, 2026