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MasimoSET® rainbow Acoustic Respiration Sensor Sample Pack adult RRa sensors
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- MasimoSET® rainbow Acoustic Respiration Sensor Sample Pack adult RRa sensors FDA UDI
- Generic Name
- Electronic acoustic stethoscope FDA UDI
- Model / Reference
- 3456 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10843997007358 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Electronic acoustic stethoscope 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
Yes
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: Electronic acoustic stethoscope
MasimoSET® rainbow Acoustic Respiration Sensor Sample Pack adult RRa sensors by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID
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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 d1f74a7c-0ff0-471c-9f6c-c2a4a42f6210 33 fields · synced May 29, 2026