Identity
- Trade Name
- ZENIX FDA UDI
- Generic Name
- Electrocardiographic electrode connector FDA UDIElectrocardiographic electrode, reusable FDA UDI
- Device Name
- Zenix ECG Accessories EUDAMEDCABLE, ECG RIGHT ANGLE LIMB LEAD SET, 12 LEAD, IEC, THOR FDA UDICABLE, LIMB LEAD ECG, IEC FDA UDI
- Model / Reference
- 8016-000131-12 EUDAMEDFDA UDI9500-000131-12 FDA UDI
- Description
- CABLE, ECG RIGHT ANGLE LIMB LEAD SET, 12 LEAD, IEC, THOR FDA UDICABLE, LIMB LEAD ECG, IEC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847946056094 EUDAMEDFDA UDI00847946046989 FDA UDI
- Basic UDI-DI
- 08479460BABE EUDAMED
- FDA Product Code
- MKJ FDA UDI
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Electrocardiographic electrode connector FDA UDIElectrocardiographic electrode, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Regulation Number
- 870.5310 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiographic electrode connector
Zenix by Zoll Medical Corporation — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Zoll Medical Corporation
Sources (3)
- FDA UDI 1dc3fd00-b09e-42d2-aefd-facd096a48f0 34 fields · synced Jul 14, 2026
- FDA UDI 3ae0fb7e-709f-4307-b726-d04645d45ab0 34 fields · synced May 30, 2026
- EUDAMED aee90cd4-0d7f-4774-83b1-6a5064fee152 61 fields · synced Jul 14, 2026