Identity
- Trade Name
- ANNE View Patient Monitor FDA UDI
- Generic Name
- Wearable multiple vital physiological parameter monitor FDA UDI
- Device Name
- Patient monitor consisting of a mobile tablet and the ANNE View software. The ANNE View Patient Monitor connects to the ANNE Chest sensor, ANNE Limb sensor, and compatible devices for the real-time display of physiological data. FDA UDI
- Model / Reference
- 900-00012 FDA UDI
- Description
- Patient monitor consisting of a mobile tablet and the ANNE View software. The ANNE View Patient Monitor connects to the ANNE Chest sensor, ANNE Limb sensor, and compatible devices for the real-time display of physiological data. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850064210132 FDA UDI
- FDA Product Code
- DRG FDA UDIKMI FDA UDIMWI FDA UDIMSX FDA UDI
- GMDN Term
- Wearable multiple vital physiological parameter monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 FDA UDI880.2400 FDA UDI870.2300 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wearable multiple vital physiological parameter monitor
ANNE View Patient Monitor by Sibel Health 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
- Sibel Health Inc.
Sources (1)
- FDA UDI 1e4bb09f-4318-436a-bd1d-100d8da9a865 33 fields · synced May 30, 2026