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DigiTrak XT Patient Cable Medium
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803157491Model DigiTrakXTPatientCable Short/Medium/Long
Identity
- Trade Name
- DigiTrak XT Patient Cable Medium EUDAMEDNOUN FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- DigiTrakXTPatientCable Short/Medium/Long EUDAMED36" patient cable (standard), for use only with the DigiTrak XT recorder FDA UDI
- Model / Reference
- DigiTrakXTPatientCable Short/Medium/Long EUDAMED989803157491 EUDAMEDDigiTrak XT Patient Cable Medium FDA UDI
- Description
- 36" patient cable (standard), for use only with the DigiTrak XT recorder FDA UDI
Identifiers
- Catalog Number
- 989803157491 FDA UDI
- Primary DI / UDI-DI
- 00884838117440 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1862N7 EUDAMED
- FDA Product Code
- IKD 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
- 890.1175 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic lead set, reusable
DigiTrak XT Patient Cable Medium by Philips Medizin Systeme Böblingen GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
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 | 0884838BM1862N7 | 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 9b08496e-7bb4-4247-8aae-aa9f7ae5cd4d 61 fields · synced Oct 6, 2026
- FDA UDI 84b9085d-5537-4990-82be-47adc1a4c9de 35 fields · synced May 30, 2026