Identity
- Trade Name
- Pathfinder SL FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
- Device Name
- PATHFINDER SL/SENTINEL 11 EVAL SYSTEM (ENG) FDA UDI
- Model / Reference
- 98000; 98200 FDA UDI
- Description
- PATHFINDER SL/SENTINEL 11 EVAL SYSTEM (ENG) FDA UDI
Identifiers
- Catalog Number
- 040-1726-02 FDA UDI
- Primary DI / UDI-DI
- 10841522125812 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic long-term ambulatory recording analyserCardiology information system application software
Pathfinder SL by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiology information system application software.
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- EZLink-C — SCOTTCARE CORPORATION, THE · Class II
- CardioConfirm — MORTARA INSTRUMENT, INC. · Class II
- EZLink — SCOTTCARE CORPORATION, THE · Class II
- Cordiana Dx16 — Cordiana Medical Informatics AG · Class II
- Epicardia 5000 — MEDICOMP, INC. · Class II
- Cardio Server — EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC · Class II
- PHILIPS HeartStart Telemedicine System — PHILIPS ELECTRONICS NORTH AMERICA CORPORATION · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spacelabs Healthcare (washington), Inc
Sources (1)
- FDA UDI bd5ed469-c78d-44a9-a932-26fddeae1212 34 fields · synced May 30, 2026