Identity
- Trade Name
- SENSINEL™ CPM ALIGNMENT TOOL FDA UDI
- Generic Name
- Wearable multiple vital physiological parameter monitoring system FDA UDI
- Model / Reference
- ADCP1100-AT-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860006382346 FDA UDI
- FDA Product Code
- MWI FDA UDIBZQ FDA UDIDPS FDA UDIDQD FDA UDIDSB FDA UDIDXH FDA UDIFLL FDA UDI
- GMDN Term
- Wearable multiple vital physiological parameter monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 FDA UDI868.2375 FDA UDI870.2340 FDA UDI870.1875 FDA UDI870.2770 FDA UDI870.2920 FDA UDI880.2910 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
No
FDA UDI
Category: Wearable multiple vital physiological parameter monitoring system
Sensinel™ Cpm Alignment Tool by Analog Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Analog Devices, Inc.
Sources (1)
- FDA UDI bc800072-c6d7-4dbc-b137-05f7bc6bfa17 33 fields · synced May 30, 2026