FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 08054242441734
·
Model: F9060/RU
·
FIAB SPA
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
Basic Information
- Brand Name
- NA
- Primary DI
- 08054242441734
- Version / Model
- F9060/RU
- Catalog Number
- F9060/RU
- Company Name
- FIAB SPA
- Labeler DUNS
- 439770017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-06-13
- Public Version
- 1
- Public Version Date
- 2020-06-22
- Public Version Status
- New
- Public Device Record Key
- 3e74a425-99ae-4044-9c9b-127124ef099b
Device Description
Disposable ECG electrodes, round-shaped Ø 60mm, Silver/Silver Chloride(SSC) sensor and stainless steel snap. F9060/RU model is suitable for rest, long term, stress or Holter ECG recording, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IKD | Cable, Electrode | Physical Medicine | 890.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35035 | Electrocardiographic electrode, single-use | A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18054242441731 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 08054242441734 | GS1 | ||||
| Package | 28054242441738 | GS1 | 10 | In Commercial Distribution | ||
| Unit of Use | 78054242441733 | GS1 |
Customer Contacts
- Phone
- +39 0558497943
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity