Identity
- Trade Name
- A&D FDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- Optum Homecare Portal W/BP FDA UDI
- Model / Reference
- UA651BLE FDA UDI
- Description
- Optum Homecare Portal W/BP FDA UDI
Identifiers
- Catalog Number
- AAA-00007 FDA UDI
- Primary DI / UDI-DI
- 00862492000346 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Self-care monitoring/reporting software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- Not 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
A&D by Optumhealth Care Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Optumhealth Care Solutions, Inc.
Sources (1)
- FDA UDI 1f69b888-5fc6-42e9-a7b1-4e3a2a5fa2a5 35 fields · synced May 30, 2026