Identity
- Trade Name
- X SERIES FDA UDI
- Generic Name
- Rechargeable professional automated external defibrillator FDA UDI
- Device Name
- X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, SPCO, ETCO2, BVM, NIBP, CPR EXPANSION PACK, REMOTE VIEW, US FDA UDI
- Model / Reference
- 601-0131112-01 FDA UDI
- Description
- X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, SPCO, ETCO2, BVM, NIBP, CPR EXPANSION PACK, REMOTE VIEW, US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847946059651 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Rechargeable professional automated external defibrillator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.5310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Rechargeable professional automated external defibrillator
The X SERIES Advanced, a portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. This device is intended for use by healthcare professionals in healthcare settings, such as emergency medical services (EMS). It consists of an external pulse generator and two skin-adhesive electrodes to monitor the rhythm and deliver the shocks; internal rechargeable batteries must be charged when not in use.
Similar devices
Also classified as Rechargeable professional automated external defibrillator.
- HeartStart — PHILIPS ELECTRONICS NORTH AMERICA CORPORATION · Class III
- M SERIES — Zoll Medical Corporation · Class III
- X SERIES — Zoll Medical Corporation · Class III
- X SERIES — Zoll Medical Corporation · Class III
- E SERIES — Zoll Medical Corporation · Class III
- X SERIES — Zoll Medical Corporation · Class II
- X SERIES — Zoll Medical Corporation · Class III
- X SERIES — Zoll Medical Corporation · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Zoll Medical Corporation
Sources (1)
- FDA UDI 505000f1-fccf-44d4-a314-d139b72fed6a 34 fields · synced Jul 5, 2026