Identity
- Trade Name
- ANNE Bedside Wireless Charger FDA UDI
- Generic Name
- Wearable multiple vital physiological parameter monitor FDA UDI
- Device Name
- Bedside charger for the ANNE Chest and ANNE Limb sensors. FDA UDI
- Model / Reference
- 900-00008 FDA UDI
- Description
- Bedside charger for the ANNE Chest and ANNE Limb sensors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850064210057 FDA UDI
- FDA Product Code
- DQA FDA UDIDRG FDA UDIFLL FDA UDIBZQ FDA UDIKMI FDA UDIMWI FDA UDIMWJ FDA UDI
- GMDN Term
- Wearable multiple vital physiological parameter monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI870.2910 FDA UDI880.2910 FDA UDI868.2375 FDA UDI880.2400 FDA UDI870.2300 FDA UDI870.2800 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wearable multiple vital physiological parameter monitor
ANNE Bedside Wireless Charger by Sibel Health Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wearable multiple vital physiological parameter monitor.
- UbiqVue — LifeSignals, Inc. · Class II
- 7-Day ANNE Chest Adhesive Shelf Box — Sibel Health Inc. · Class II
- Central Hub Speaker — Sibel Health Inc. · Class II
- Sibel Spacelabs Trek Charger — Sibel Health Inc. · Class II
- ANNE View Patient Monitor — Sibel Health Inc. · Class II
- ANNE Chest Sensor Kit — Sibel Health Inc. · Class II
- 7-Day ANNE Chest Adhesive Pouch — Sibel Health Inc. · Class II
- Central Hub CMS — Sibel Health Inc. · Class II
Cleared under the same submission
K240251 also covers:
- 1-Day ANNE Chest Adhesive Pouch — Sibel Health Inc.
- 7-Day ANNE Chest Adhesive Pouch — Sibel Health Inc.
- 7-Day ANNE Chest Adhesive Shelf Box — Sibel Health Inc.
- ANNE Chest — Sibel Health Inc.
- ANNE Chest Sensor — Sibel Health Inc.
- ANNE Chest Sensor Kit — Sibel Health Inc.
- Sibel Spacelabs Trek Charger — Sibel Health Inc.
- Sibel Spacelabs Trek Chest Patch — Sibel Health Inc.
- Sibel Spacelabs Trek Chest Patch Adhesive — Sibel Health Inc.
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 030d657d-db97-4b3a-b41e-e754b48e7038 34 fields · synced May 30, 2026