Identity
- Trade Name
- Portrait RRP01 EUDAMEDFDA UDI
- Generic Name
- Thoracic electrical impedance electrode array, single-use FDA UDI
- Device Name
- Portrait Respiration Rate Electrode Patch EUDAMEDBODY-WORN RESP ELECTRODE PATCH FDA UDI
- Model / Reference
- 5514119 EUDAMEDRRP01 FDA UDI
- Description
- BODY-WORN RESP ELECTRODE PATCH FDA UDI
Identifiers
- Catalog Number
- 5514119 FDA UDI
- Primary DI / UDI-DI
- 00195278223401 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00262HC EUDAMED
- 510(k) Number
- K230626 FDA UDI
- FDA Product Code
- DQA FDA UDIMWI FDA UDIMSX FDA UDIBZQ FDA UDIDRG FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Thoracic electrical impedance electrode array, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI870.2300 FDA UDI868.2375 FDA UDI870.2910 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Portrait RRP01 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 | 8406821BUG00262HC | 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 f7ac1cab-c3db-409c-acbc-2ecb41bda16e 61 fields · synced Oct 6, 2026
- FDA UDI ac985d79-488f-47b9-a60b-fd86330adf8f 36 fields · synced May 30, 2026