FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 08054242444933
·
Model: U7959
·
FIAB SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 08054242444933
- Version / Model
- U7959
- Catalog Number
- U7959
- Company Name
- FIAB SPA
- Labeler DUNS
- 439770017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-12
- Public Version
- 3
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- f7b94732-a008-4faf-8026-a9dc7f9d1957
Device Description
Disposable multifunction electrodes for external defibrillation, transthoracic synchronized cardioversion, transcutaneous cardiac stimulation and ECG monitoring. Designed for direct connection to cables and defibrillators, they are characterized by a low impedance and a reduced stimulation threshold, with an excellent adaptability to the patient’s skin. The protective foam insulator and the safety plug eliminate every risk of electric micro-shock. Electrodes equipped with connector for defibrillators CU MEDICAL SYSTEM / CMOS DRAKE. Adult version.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | Cardiovascular | 870.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44771 | External defibrillation electrode, adult, single-use | An electrical conductor intended to be used in pairs to transmit a controlled electrical shock from an external defibrillator to a post-pubescent patient to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with self-affixing pads (the electrodes) designed to be applied to the chest or back of the patient so that the discharge passes across the region of the heart. It may also be used for electrocardiographic analysis prior to shock delivery. The device may remain applied to the patient during stages of treatment. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18054242444930 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08054242444933 | GS1 |
Customer Contacts
- Phone
- +390558497943
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103783 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 95 Degrees Fahrenheit