Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Patient monitor remote control FDA UDI
- Device Name
- USB Remote Control EUDAMED
- Model / Reference
- 2039040-001 EUDAMEDUSB Remote Control FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682104449 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00059HD EUDAMED
- 510(k) Number
- K131414 FDA UDI
- FDA Product Code
- FLL FDA UDIDPZ FDA UDIBZK FDA UDICAP FDA UDINHO FDA UDIDXN FDA UDIBZQ FDA UDINHQ FDA UDINHP FDA UDIORT FDA UDICBS FDA UDICBR FDA UDIKOI FDA UDIOLT FDA UDICCK FDA UDIDSI FDA UDIGWQ FDA UDIKRB FDA UDIMHX FDA UDIDPS FDA UDIDSK FDA UDIOMC FDA UDICCL FDA UDIDSJ FDA UDIGWJ FDA UDIDQA FDA UDIOLW FDA UDICBQ FDA UDIDQK FDA UDIDXG FDA UDIBZL FDA UDIMLD FDA UDIDRT FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient monitor remote control FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI870.2710 FDA UDI868.1850 FDA UDI868.2600 FDA UDI868.1500 FDA UDI870.1130 FDA UDI868.2375 FDA UDI882.1400 FDA UDI868.1620 FDA UDI868.1700 FDA UDI868.2775 FDA UDI868.1400 FDA UDI870.1025 FDA UDI870.1915 FDA UDI870.2340 FDA UDI870.1110 FDA UDI868.1720 FDA UDI870.1100 FDA UDI882.1900 FDA UDI870.2700 FDA UDI870.1425 FDA UDI870.1435 FDA UDI868.1730 FDA UDI870.2300 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
USB Remote Control 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 | 8406821BUG00059HD | 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 7eb716c4-502c-4272-8843-31a7e068e64d 61 fields · synced Oct 8, 2026
- FDA UDI 3a81b4d3-2cb2-4c59-8907-8cac05666a66 35 fields · synced May 30, 2026