FDA UDI
Not in Commercial Distribution
🇺🇸 United States
g.HIamp
DI: EBCI70020
·
Model: 144-Channel Amplifier
·
g.tec medical engineering GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- g.HIamp
- Primary DI
- EBCI70020
- Version / Model
- 144-Channel Amplifier
- Catalog Number
- 7002
- Company Name
- g.tec medical engineering GmbH
- Labeler DUNS
- 300916041
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-12
- Public Version
- 5
- Public Version Date
- 2019-01-31
- Public Version Status
- Update
- Public Device Record Key
- cd7d58cc-eb1b-4b63-8b1e-a010e240e4e9
- Distribution End Date
- 2019-01-31
Device Description
The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals.
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
- No
- 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 |
|---|---|---|---|---|
| GWL | Amplifier, Physiological Signal | Neurology | 882.1835 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32521 | Multiple physiological signal amplifier | An electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EBCI70020 | HIBCC |
Customer Contacts
- Phone
- +437251222400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123255 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Channel Number 144 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 25 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius