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Vivo 45/45LS/Nippy 4/4+ Click-in Battery
EUDAMEDFDA UDIClass I (EU MDR)
Ref 006265Model Class I Ventilator AccessoriesRef 220000Model Vivo 45/NIPPY 4Ref 231000Model Vivo 45 LS/ NIPPY 4+
Identity
- Trade Name
- Vivo 45/45LS/Nippy 4/4+ Click-in Battery EUDAMEDVivo 45 EUDAMEDNIPPY 4+ EUDAMEDVivo 45 LS FDA UDI
- Generic Name
- Secondary battery FDA UDI
- Device Name
- Click-In Battery FDA UDI
- Model / Reference
- Class I Ventilator Accessories EUDAMED006265 EUDAMEDFDA UDIVivo 45/NIPPY 4 EUDAMED220000 EUDAMEDVivo 45 LS/ NIPPY 4+ EUDAMED231000 EUDAMED
- Description
- Click-In Battery FDA UDI
Identifiers
- Catalog Number
- 006265 FDA UDI
- Primary DI / UDI-DI
- 07321820062652 EUDAMEDFDA UDI07321822200007 EUDAMED07321822310003 EUDAMED
- Basic UDI-DI
- 7321820139999H EUDAMED7321822209999Z EUDAMED732182230999AC 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 EUDAMEDZ12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
- GMDN Term
- Secondary battery FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Sweden EUDAMEDIreland 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
EUDAMEDEUDAMED
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
Vivo 45/45LS/Nippy 4/4+ Click-in Battery 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 (4)
- EUDAMED b7fcc2a3-1340-4de7-a460-e0305c3da8c5 61 fields · synced Oct 6, 2026
- EUDAMED 58f40555-d77e-4dfa-9118-ac9ed7010d83 61 fields · synced May 17, 2026
- EUDAMED 25c938de-496b-4e7f-83b6-dde40fd00ddc 61 fields · synced May 18, 2026
- FDA UDI f47633e7-5e3b-4f30-bac0-8f2bdfcb96f8 36 fields · synced May 26, 2026