Identity
- Trade Name
- Fast-Fix ECG Electrode FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- The Fast-Fix ECG Electrode is a user-friendly, single-use electrode meant to use with Faros ECG devices. The electrode is affixed to the patient's chest, and it transfers the hearts biosignal from the body to the Faros ECG device. FDA UDI
- Model / Reference
- 901155 FDA UDI
- Description
- The Fast-Fix ECG Electrode is a user-friendly, single-use electrode meant to use with Faros ECG devices. The electrode is affixed to the patient's chest, and it transfers the hearts biosignal from the body to the Faros ECG device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430035220335 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
Category: Electrocardiographic electrode, single-use
Fast-Fix ECG Electrode by Bittium Biosignals , Ltd. — 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
- Bittium Biosignals , Ltd.
Sources (1)
- FDA UDI 79f8bd3f-54c4-46a3-8ce0-db3473872b86 34 fields · synced May 30, 2026