Identity
- Trade Name
- Rad-97 Home Use EUDAMEDMasimo FDA UDI
- Generic Name
- Pulse Co-oximeter FDA UDI
- Device Name
- Rad-97 EUDAMEDKit, Rad-97, Homecare FDA UDI
- Model / Reference
- 9783 EUDAMEDFDA UDI
- Description
- Kit, Rad-97, Homecare FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843997016605 EUDAMEDFDA UDI
- Basic UDI-DI
- 084399700000Z0T3A01V000EM EUDAMED
- Direct Marketing DI
- 00843997013673 EUDAMED
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Pulse Co-oximeter FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
Category: Pulse Co-oximeter
Masimo by Masimo Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulse Co-oximeter.
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- Radius-7 — MASIMO CORPORATION · Class II
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- Radius-PPG — MASIMO CORPORATION · Class II
- Rad-97 — MASIMO CORPORATION · Class II
- Rad-97 — MASIMO CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (2)
- FDA UDI c6d5a073-1670-4062-9a7b-50f15a1989c9 35 fields · synced Jun 20, 2026
- EUDAMED 0a617c97-4c8e-44a7-bf9b-315c38ac4cf3 61 fields · synced Jun 20, 2026