Identity
- Trade Name
- Radius T FDA UDI
- Generic Name
- Wireless patient thermometer, single-use FDA UDI
- Device Name
- Radius T Continuous Thermometer FDA UDI
- Model / Reference
- 4823 FDA UDI
- Description
- Radius T Continuous Thermometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843997004473 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Wireless patient thermometer, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wireless patient thermometer, single-use
Radius T by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- TempTraq — Blue Spark Technologies, Inc. · Class II
- Radius T — MASIMO CORPORATION · Class II
- Radius PPG — MASIMO CORPORATION · 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 0e9c41c3-35f6-4f41-825f-8bd4dcf711cc 35 fields · synced May 31, 2026