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Remote Start/Stop (Vivo 45/Nippy 4)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 006649Model Class I Ventilator Accessories
Identity
- Trade Name
- Remote Start/Stop (Vivo 45/Nippy 4) EUDAMEDVivo 45 LS FDA UDI
- Generic Name
- Assistive remote control FDA UDI
- Device Name
- Remote Start/Stop FDA UDI
- Model / Reference
- Class I Ventilator Accessories EUDAMED006649 EUDAMEDFDA UDI
- Description
- Remote Start/Stop FDA UDI
Identifiers
- Catalog Number
- 006649 FDA UDI
- Primary DI / UDI-DI
- 07321820066490 EUDAMEDFDA UDI
- Basic UDI-DI
- 7321820139999H EUDAMED
- 510(k) Number
- K193586 FDA UDI
- FDA Product Code
- CBK FDA UDINOU FDA UDI
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Assistive remote control FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Sweden 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
No
FDA UDI
Remote Start/Stop (Vivo 45/Nippy 4) by Breas Medical AB — 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 | 7321820139999H | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (2)
- EUDAMED f8ea0263-3f81-42a7-921b-ddf3f082076d 61 fields · synced Jun 17, 2026
- FDA UDI 631d1cbe-e43c-4ca5-b891-317b7dd17f1a 36 fields · synced May 30, 2026