Identity
- Trade Name
- QT ECG FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- PCA-A200 Electrode Cable is intended to be used with ECG devices. The Electrode Cable is used to connect electrodes of QT Medical, Inc. placed at appropriate sites on the patient to the Monitor/Defibrillator for general monitoring and/or diagnostic evaluation by healthcare professionals. FDA UDI
- Model / Reference
- PCA-A200 FDA UDI
- Description
- PCA-A200 Electrode Cable is intended to be used with ECG devices. The Electrode Cable is used to connect electrodes of QT Medical, Inc. placed at appropriate sites on the patient to the Monitor/Defibrillator for general monitoring and/or diagnostic evaluation by healthcare professionals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872980339 FDA UDI
- FDA Product Code
- IKD FDA UDI
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
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
Qt Ecg by QT Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- QT Medical, Inc.
Sources (1)
- FDA UDI 6aa6335d-de6f-4a4c-ac27-da45f218cfc8 35 fields · synced Jun 8, 2026