Identity
- Trade Name
- NICU ECG LEADWIRE SET EUDAMEDNA FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- CS ONE ECG Cable and Leadwires EUDAMEDCABLE ASSEMBLY ECG 3 LEAD NEO AHA SHORT FDA UDI
- Model / Reference
- 2080557-002 EUDAMEDFDA UDI
- Description
- CABLE ASSEMBLY ECG 3 LEAD NEO AHA SHORT FDA UDI
Identifiers
- Catalog Number
- 2080557-002 FDA UDI
- Primary DI / UDI-DI
- 00840682138055 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00121GR EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Market of Registration
- France 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiographic lead set, reusable
Nicu Ecg Leadwire Set by Ge Medical Systems Information Technologies, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
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- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00121GR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GE Medical Systems Information Technologies, Inc.
- EUDAMED SRN
- US-MF-000017529
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED df0f1396-9cad-48cf-8f11-7b559ee623b1 61 fields · synced Jul 17, 2026
- FDA UDI dbfa0f81-5e64-4117-9e47-7b289d78aa6e 35 fields · synced May 30, 2026