Identity
- Trade Name
- TruSignal SpO2 FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- TRUSIGNAL SPO2 TS-F4-MC FDA UDI
- Model / Reference
- TS-F4-MC FDA UDI
- Description
- TRUSIGNAL SPO2 TS-F4-MC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682103169 FDA UDI
- 510(k) Number
- K021955 FDA UDI
- FDA Product Code
- DQA FDA UDIDPZ FDA UDI
- GMDN Term
- Pulse oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI870.2710 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
MR Unsafe FDA UDI
TruSignal SpO2 by GE Healthcare Finland Oy — 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
- GE Healthcare Finland Oy
Sources (1)
- FDA UDI 51417f4c-a76c-474f-a0db-d79bf805bc07 37 fields · synced May 31, 2026