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MasimoSET uSpO2 Masimo SET Oximetry Cable, USB signal extraction pulse oximeter
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- MasimoSET uSpO2 Masimo SET Oximetry Cable, USB signal extraction pulse oximeter FDA UDI
- Generic Name
- Patient monitoring system module, pulse oximetry FDA UDI
- Device Name
- MasimoSET uSpO2 Masimo SET Oximetry Cable, USB signal extraction pulse oximeter FDA UDI
- Model / Reference
- 3412 FDA UDI
- Description
- MasimoSET uSpO2 Masimo SET Oximetry Cable, USB signal extraction pulse oximeter FDA UDI
Identifiers
- Catalog Number
- 3412 FDA UDI
- Primary DI / UDI-DI
- 00843997007252 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Patient monitoring system module, pulse oximetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Patient monitoring system module, pulse oximetry
MasimoSET uSpO2 Masimo SET Oximetry Cable, USB signal extraction pulse oximeter by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Patient monitoring system module, pulse oximetry.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA UDI 1241e68c-c335-476b-a8a8-10e753cc6865 36 fields · synced Jun 8, 2026