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PHILIPS HeartStart FR3 with Text and Small Soft Case
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- PHILIPS HeartStart FR3 with Text and Small Soft Case FDA UDI
- Generic Name
- Non-rechargeable public automated external defibrillator FDA UDI
- Device Name
- FR3 Text, US English, Small Soft Bundle FDA UDI
- Model / Reference
- 860365 FDA UDI
- Description
- FR3 Text, US English, Small Soft Bundle FDA UDI
Identifiers
- Catalog Number
- 860365 FDA UDI
- Primary DI / UDI-DI
- 00884838051454 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Non-rechargeable public 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 FR3 with Text and Small Soft Case by Philips Electronics North America Corporation — Class III — FDA UDI — listed in FDA GUDID
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 |
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Manufacturer
- Manufacturer
- Philips Electronics North America Corporation
Sources (1)
- FDA UDI 057d6da9-4827-4216-acdb-a030f6b652a9 35 fields · synced May 30, 2026