Identity
- Trade Name
- O3 FDA UDI
- Generic Name
- Cerebral oximeter FDA UDI
- Device Name
- O3 Sensor Pediatric Adhesive Sensor FDA UDI
- Model / Reference
- 4235 FDA UDI
- Description
- O3 Sensor Pediatric Adhesive Sensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10843997010808 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Cerebral oximeter 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cerebral oximeter
O3 by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- INVOS — Covidien LP · Class II
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 a4f69da1-3d8b-4736-a3c4-fca2bc26d196 35 fields · synced Jun 8, 2026