Identity
- Trade Name
- SENTINEL FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
- Device Name
- SENTINEL 11 / PATHFINDER SL KIT IT FDA UDI
- Model / Reference
- Sentinal 11 FDA UDI
- Description
- SENTINEL 11 / PATHFINDER SL KIT IT FDA UDI
Identifiers
- Catalog Number
- 040-1749-01 FDA UDI
- Primary DI / UDI-DI
- 10841522129339 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
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sentinel 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 3f7ee39f-792c-4fe6-b1f3-e2f7e4c8893e 35 fields · synced Jun 1, 2026