Patient Cable Lead Set
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- WAM/AMXX Lead Set EUDAMEDPatient Cable Lead Set FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Patient cable cleared with ELI 380 FDA UDI
- Model / Reference
- 9293-047-61 EUDAMEDFDA UDI901006 EUDAMED
- Description
- Patient cable cleared with ELI 380 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812345025620 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732094GMN901006BNJ EUDAMED
- 510(k) Number
- K142105 FDA UDI
- FDA Product Code
- DPS 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
- 870.2340 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Electrocardiographic lead set, reusable
Patient Cable Lead Set by Mortara Instrument, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K142105 also covers:
- ELI 380 — MORTARA INSTRUMENT, INC.
- ELI 380 — MORTARA INSTRUMENT, INC.
- ELI 380 — MORTARA INSTRUMENT, INC.
- ELI 380 — MORTARA INSTRUMENT, INC.
- ELI 380 — MORTARA INSTRUMENT, INC.
- ELI 380 — MORTARA INSTRUMENT, INC.
- ELI 380 — MORTARA INSTRUMENT, INC.
- ELI 380 — MORTARA INSTRUMENT, INC.
- ELI 380 — MORTARA INSTRUMENT, INC.
- ELI 380 — MORTARA INSTRUMENT, INC.
- ELI 380 — MORTARA INSTRUMENT, INC.
- ELI 380 — MORTARA INSTRUMENT, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mortara Instrument, Inc.
Sources (2)
- FDA UDI 469a3935-a9eb-4039-b009-91615f089c08 36 fields · synced Aug 1, 2026
- EUDAMED ab82ab7e-5eff-48e2-905f-2a0bd28df320 61 fields · synced Aug 1, 2026