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SpO2 Module
EUDAMEDFDA UDIClass I (EU MDR)
Ref 006369Model Class I Ventilator Accessories
Identity
- Trade Name
- SpO2 Module EUDAMEDVivo 45 LS, Vivo 65 FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Masimo SpO2 Cable FDA UDI
- Model / Reference
- Class I Ventilator Accessories EUDAMED006369 EUDAMEDFDA UDI
- Description
- Masimo SpO2 Cable FDA UDI
Identifiers
- Catalog Number
- 006369 FDA UDI
- Primary DI / UDI-DI
- 07321820063697 EUDAMEDFDA UDI
- Basic UDI-DI
- 7321820139999H EUDAMED
- FDA Product Code
- CBK FDA UDINOU FDA UDI
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable 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
Yes
FDA UDI
SpO2 Module 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 e8afea34-9b74-4143-92b4-941d91fe4b67 61 fields · synced Jun 19, 2026
- FDA UDI 5d1041e6-a7ee-4120-be69-2dbccf73132d 36 fields · synced May 29, 2026