Identity
- Trade Name
- HomeSafe Standard Personal Help Pendant FDA UDI
- Generic Name
- Vulnerable patient home alert system FDA UDI
- Device Name
- 324PHB Personal Help Buton / Neckcord FDA UDI
- Model / Reference
- 300005057791 FDA UDI
- Description
- 324PHB Personal Help Buton / Neckcord FDA UDI
Identifiers
- Catalog Number
- 324PHB FDA UDI
- Primary DI / UDI-DI
- 00884838100060 FDA UDI
- FDA Product Code
- ILQ FDA UDI
- GMDN Term
- Vulnerable patient home alert system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3710 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vulnerable patient home alert system
HomeSafe Standard Personal Help Pendant by Lifeline Systems, 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
- Lifeline Systems, Inc.
Sources (1)
- FDA UDI a8aedf31-df6e-45ed-8e80-83bd7c37e773 34 fields · synced Jun 8, 2026