Identity
- Trade Name
- Spacelabs Healthcare FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
- Device Name
- CARDIOCALLST80X4 039/0249/1 FDA UDI
- Model / Reference
- EVENTREC FDA UDI
- Description
- CARDIOCALLST80X4 039/0249/1 FDA UDI
Identifiers
- Catalog Number
- CCST80X4 FDA UDI
- Primary DI / UDI-DI
- 10841522106903 FDA UDI
- FDA Product Code
- DXH FDA UDI
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2920 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
No
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
No
FDA UDI
Spacelabs Healthcare 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 09347809-d132-4554-9182-227ba8f35503 36 fields · synced May 30, 2026