Identity
- Trade Name
- WAM/AMXX Lead Set EUDAMEDPatient Cable FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Patient cable cleared with Resting ECG and Stress FDA UDI
- Model / Reference
- 9293-033-52 EUDAMEDFDA UDI901011 EUDAMED
- Description
- Patient cable cleared with Resting ECG and Stress FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812345021790 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732094GMN901011ENE EUDAMED
- FDA Product Code
- MHX 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
- 870.1025 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic lead set, reusable
Patient Cable by Mortara Instrument, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K022618 also covers:
- Patient Cable — MORTARA INSTRUMENT, INC.
- XScribe — MORTARA INSTRUMENT, INC.
- XScribe — MORTARA INSTRUMENT, INC.
- XScribe — MORTARA INSTRUMENT, INC.
- XScribe — MORTARA INSTRUMENT, INC.
- XScribe — MORTARA INSTRUMENT, INC.
- XScribe — MORTARA INSTRUMENT, INC.
- XScribe — MORTARA INSTRUMENT, INC.
- XScribe — MORTARA INSTRUMENT, INC.
- XScribe — MORTARA INSTRUMENT, INC.
- XScribe — MORTARA INSTRUMENT, INC.
- XScribe — MORTARA INSTRUMENT, INC.
K092663 also covers:
- Patient Cable — MORTARA INSTRUMENT, INC.
- Patient Cable — MORTARA INSTRUMENT, INC.
- Patient Cable — MORTARA INSTRUMENT, INC.
- Patient Cable — MORTARA INSTRUMENT, INC.
- Patient Cable — MORTARA INSTRUMENT, INC.
- Patient Cable — MORTARA INSTRUMENT, INC.
- Patient Cable — MORTARA INSTRUMENT, INC.
- Patient Cable — MORTARA INSTRUMENT, INC.
- Patient Cable — MORTARA INSTRUMENT, INC.
- Patient Cable Lead Set — MORTARA INSTRUMENT, INC.
- Patient Cable Lead Set — MORTARA INSTRUMENT, INC.
- Patient Cable Lead Set — MORTARA INSTRUMENT, INC.
K101115 also covers:
- ELI 150c — MORTARA INSTRUMENT, INC.
- ELI 150c — MORTARA INSTRUMENT, INC.
- ELI 150c — MORTARA INSTRUMENT, INC.
- ELI 150c — MORTARA INSTRUMENT, INC.
- ELI 150c — MORTARA INSTRUMENT, INC.
- ELI 150c — MORTARA INSTRUMENT, INC.
- ELI 150c — MORTARA INSTRUMENT, INC.
- ELI 150c — MORTARA INSTRUMENT, INC.
- ELI 150c — MORTARA INSTRUMENT, INC.
- ELI 150c — MORTARA INSTRUMENT, INC.
- ELI 150c — MORTARA INSTRUMENT, INC.
- ELI 150c — MORTARA INSTRUMENT, INC.
K101403 also covers:
K102206 also covers:
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 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 f6b77589-cb0b-4d90-9a85-a9a4e14db0ea 36 fields · synced Aug 3, 2026
- EUDAMED ab886a05-57f2-4e50-9a41-89ddfbb40746 61 fields · synced Aug 3, 2026