Identity
- Trade Name
- TruSignal SpO2 FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- TruSignal SpO2 Interconnect Cable EUDAMEDTRUSIGNAL SPO2 TS-G3 FDA UDI
- Model / Reference
- TS-G3 EUDAMEDFDA UDI
- Description
- TRUSIGNAL SPO2 TS-G3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278984784 EUDAMEDFDA UDI
- Basic UDI-DI
- 08406821BUG005277D EUDAMED
- 510(k) Number
- K093881 FDA UDI
- FDA Product Code
- DPZ FDA UDIDQA FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Pulse oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2710 FDA UDI870.2700 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 Interconnect Cable by GE Healthcare Finland Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08406821BUG005277D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (2)
- EUDAMED 18840dd7-5ffc-41fe-b9fd-c4304a068417 61 fields · synced Oct 8, 2026
- FDA UDI 9de14c47-d191-4c41-81b8-49b7cbeb42d3 35 fields · synced May 29, 2026