Identity
- Trade Name
- PHILIPS HeartStart HOME FDA UDI
- Generic Name
- Home automated external defibrillator FDA UDI
- Model / Reference
- 861284 FDA UDI
Identifiers
- Catalog Number
- 861284 FDA UDI
- Primary DI / UDI-DI
- 00884838076716 FDA UDI
- FDA Product Code
- NSA FDA UDI
- GMDN Term
- Home automated external defibrillator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.5310 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
PHILIPS HeartStart HOME by Philips Electronics North America Corporation — Class III — 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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Electronics North America Corporation
Sources (1)
- FDA UDI dfa11788-4fa8-49d5-92ab-6dadd02ee82e 35 fields · synced May 30, 2026