DigiTrak XT Patient Cable Short
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- DigiTrak XT Patient Cable Short EUDAMEDNOUN FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- DIGITRAK XT PATIENT CABLE S/M/L EUDAMED24" patient cable, for use only with the DigiTrak XT recorder, FDA UDI
- Model / Reference
- 989803157481 EUDAMEDDigiTrak XT Patient Cable Short FDA UDI
- Description
- 24" patient cable, for use only with the DigiTrak XT recorder, FDA UDI
Identifiers
- Catalog Number
- 989803157481 FDA UDI
- Primary DI / UDI-DI
- 00884838032941 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM513SU EUDAMED
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z12050480 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Electrocardiographic lead set, reusable
DigiTrak XT Patient Cable Short by Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM513SU | 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 a44d3ee2-33c9-464a-b498-5113612b8881 61 fields · synced Jul 26, 2026
- FDA UDI fb82e89a-2dc9-4b08-8e4a-2941755cdb39 36 fields · synced May 30, 2026