Identity
- Trade Name
- Pathfinder FDA UDI
- Generic Name
- Cardiology information system application software FDA UDI
- Device Name
- PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG) FDA UDI
- Model / Reference
- 98000, 98200 FDA UDI
- Description
- PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG) FDA UDI
Identifiers
- Catalog Number
- 040-1726-01 FDA UDI
- Primary DI / UDI-DI
- 10841522124563 FDA UDI
- FDA Product Code
- DXH FDA UDIDQK FDA UDI
- GMDN Term
- Cardiology information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2920 FDA UDI870.1425 FDA UDI
- Commercial Distribution
- Not 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
Pathfinder by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Spacelabs Healthcare (washington), Inc
Sources (1)
- FDA UDI 8c036045-c6b4-4d3f-828e-bc0e8c29bfeb 35 fields · synced Jun 8, 2026