Q-Stress Patient Cable
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- WAM/AMXX Lead Set EUDAMEDQ-Stress Patient Cable FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Cable cleared with Q-Stress Stress Exercise System FDA UDI
- Model / Reference
- 60-00186-01 EUDAMEDFDA UDI901006 EUDAMED
- Description
- Cable cleared with Q-Stress Stress Exercise System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812345024777 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732094GMN901006CNL EUDAMED
- 510(k) Number
- K152944 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
Q-Stress Patient Cable 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.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
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- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K152944 also covers:
- AM12Q — MORTARA INSTRUMENT, INC.
- Patient Cable Lead Set — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — 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 7852f692-5811-4107-9254-b157d45db0cc 36 fields · synced Jul 29, 2026
- EUDAMED 10b83767-4d5a-4b25-b30a-21b10c3e3290 61 fields · synced Jul 29, 2026