Identity
- Trade Name
- Masimo W1 FDA UDI
- Generic Name
- Wearable multiple vital physiological parameter monitoring system FDA UDI
- Device Name
- Masimo W1, Global, Switzerland FDA UDI
- Model / Reference
- 95080-104 FDA UDI
- Description
- Masimo W1, Global, Switzerland FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843997017503 FDA UDI
- 510(k) Number
- K232512 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Wearable multiple vital physiological parameter monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wearable multiple vital physiological parameter monitoring system
Masimo W1 by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K232512 also covers:
- Masimo W1 — MASIMO CORPORATION
- Masimo W1 — MASIMO CORPORATION
- Masimo W1 — MASIMO CORPORATION
- Masimo W1 — MASIMO CORPORATION
- Masimo W1 — MASIMO CORPORATION
- Masimo W1 — MASIMO CORPORATION
- Masimo W1 — MASIMO CORPORATION
- Masimo W1 — MASIMO CORPORATION
- Masimo W1 — MASIMO CORPORATION
- Masimo W1 — MASIMO CORPORATION
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 0e3d9756-6792-48a8-a6f7-3a01d0cda4b7 36 fields · synced Jun 1, 2026