Identity
- Trade Name
- QT ECG FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG electrode meant to use with QT ECG recorder. The design of the prepositioned Electrode Strip gives the user an easy way of applying the collection of electrodes in their correct locations, thereby reducing electrode placement errors. This is for special adult body type. FDA UDI
- Model / Reference
- QTENS126A FDA UDI
- Description
- The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG electrode meant to use with QT ECG recorder. The design of the prepositioned Electrode Strip gives the user an easy way of applying the collection of electrodes in their correct locations, thereby reducing electrode placement errors. This is for special adult body type. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872980315 FDA UDI
- FDA Product Code
- DRX FDA UDI
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiographic electrode, single-use
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 46c64d14-677d-4164-baf7-4a851742b06e 35 fields · synced Jun 6, 2026