Identity
- Trade Name
- RD SET FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- RD SET Neo SpO2, PR, PI, PVI Neonatal/Adult Pulse Oximeter Adhesive Sensor FDA UDI
- Model / Reference
- 4003 FDA UDI
- Description
- RD SET Neo SpO2, PR, PI, PVI Neonatal/Adult Pulse Oximeter Adhesive Sensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843997009591 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter probe, single-use 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: Pulse oximeter probe, single-use
Rd Set by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulse oximeter probe, single-use.
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- APK — Apk Technology · Class II
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- BluSat — OSI OPTOELECTRONICS, INC. · Class II
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- Nonin — Nonin Medical, Inc. · 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 bb7a5934-e2e9-468a-81ed-387e83c86eba 35 fields · synced Jun 8, 2026