Identity
- Trade Name
- HeartStart FDA UDI
- Generic Name
- Cardiopulmonary resuscitation kit, single-use FDA UDI
- Device Name
- Fast Response Kit, FR3 FDA UDI
- Model / Reference
- FR3 Fast Response Kit FDA UDI
- Description
- Fast Response Kit, FR3 FDA UDI
Identifiers
- Catalog Number
- 989803150111 FDA UDI
- Primary DI / UDI-DI
- 00884838055728 FDA UDI
- FDA Product Code
- KGB FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5570 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiopulmonary resuscitation kit, single-use
HeartStart by Philips Electronics North America Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary resuscitation kit, single-use.
- Ambu® SPUR® II Adult Resuscitator — Ambu A/S · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
- Ever Ready First Aid — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Ambu® SPUR® II Adult Resuscitator — Ambu A/S · Class II
- Aquatic Solutions — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- BROSELOW™ — Airlife, Inc. · Class II
- Ambu® SPUR® II Adult Resuscitator — Ambu A/S · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Philips Electronics North America Corporation
Sources (1)
- FDA UDI 43e00974-0b70-4eb7-a57a-65947e0b0e27 35 fields · synced May 30, 2026