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rainbow SET Pulse CO-Oximetry Cable, GE Carescape Sp02, Masimo
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 4234
Identity
- Trade Name
- rainbow SET Pulse CO-Oximetry Cable, GE Carescape Sp02, Masimo EUDAMEDCarescape Sp02 - Masimo rainbow SET Pulse CO-Oximetry FDA UDI
- Generic Name
- Patient monitoring system module, pulse oximetry FDA UDI
- Device Name
- rainbow SET EUDAMEDPulse CO-Oximetry Module FDA UDI
- Model / Reference
- 4234 EUDAMEDFDA UDI
- Description
- Pulse CO-Oximetry Module FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843997013871 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00843997013871 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
- GMDN Term
- Patient monitoring system module, pulse oximetry FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
rainbow SET Pulse CO-Oximetry Cable, GE Carescape Sp02, Masimo by Masimo Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00843997013871 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Masimo Corporation
- EUDAMED SRN
- US-MF-000010641
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED dbce35f6-c648-437a-a231-1bc56f2c14cb 61 fields · synced Jun 18, 2026
- FDA UDI d3af8742-5984-4174-8621-8a1ca172ee83 35 fields · synced May 29, 2026