FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 08054242448184
·
Model: F2080P
·
FIAB SPA
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
Basic Information
- Brand Name
- NA
- Primary DI
- 08054242448184
- Version / Model
- F2080P
- Catalog Number
- F2080P
- 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
- 2
- Public Version Date
- 2020-11-18
- Public Version Status
- Update
- Public Device Record Key
- fb874837-35df-46b8-9781-3acebffdf494
Device Description
Disposable ECG electrodes with solid gel, round-shaped Ø 40mm, Silver/Silver Chloride(SSC) sensor and stainless steel snap. F2080P model is is made of non woven fabric. The fabric is made of plastic polyethylene fiber (and not natural fiber) that guarantees the transpiration of the skin, but at the same time the resistance to liquids with which they may come into contact during their use. F2080P is suitable for rest, long term, stress or Holter ECG recording, with a direct application onto
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 |
|---|---|---|---|---|
| DRX | Electrode, Electrocardiograph | Cardiovascular | 870.2360 | 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 | 18054242448181 | GS1 | 24 | In Commercial Distribution | ||
| Primary | 08054242448184 | GS1 | ||||
| Package | 28054242448188 | GS1 | 10 | In Commercial Distribution | ||
| Unit of Use | 78054242448183 | 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