FDA UDI
In Commercial Distribution
🇺🇸 United States
Isolation Transformer ‘GP’ 220-240 VAC 50/60 Hz
DI: 08056446900666
·
Model: B9700041000
·
EB NEURO SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Isolation Transformer ‘GP’ 220-240 VAC 50/60 Hz
- Primary DI
- 08056446900666
- Version / Model
- B9700041000
- Company Name
- EB NEURO SPA
- Labeler DUNS
- 339182263
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-24
- Public Version
- 1
- Public Version Date
- 2019-06-03
- Public Version Status
- New
- Public Device Record Key
- 7274fa49-51ad-41c9-aac2-8cbdf62eb8b8
Device Description
Isolation Transformer for EEG/EMG/EP systems
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IKN | Electromyograph, Diagnostic | Physical Medicine | 890.1375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16933 | Constant-voltage transformer | A device designed to deliver a fixed, predetermined voltage that is one of a limited range of input voltage variations. The device receives a fluctuating input voltage and transforms this fluctuating voltage into a steady (constant) output helping to avoid such fluctuations which are present in the electrical system. These fluctuations may be known as spikes, and can be harmful to devices with sensitive electronics. This device may be inserted into new or existing electrical systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056446900666 | GS1 |
Customer Contacts
- Phone
- +390554565111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K073415 | 000 |