FDA UDI
In Commercial Distribution
🇺🇸 United States
GD
DI: 00862186000348
·
Model: Prep-Check Plus, 37 pin
·
General Devices
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GD
- Primary DI
- 00862186000348
- Version / Model
- Prep-Check Plus, 37 pin
- Catalog Number
- EIM 107-37A
- Company Name
- General Devices
- Labeler DUNS
- 101394815
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7717cc63-d476-4a39-b51b-f68590262e16
Device Description
The Prep-Check Plus, 37 pin, is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 37 Lead EEG with 37 Pin Female "D" Connector (All 37 Pins Wired) .
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| GZO | Device, Galvanic Skin Response Measurement | Neurology | 882.1540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35028 | Electrocardiographic electrode tester | An instrument designed to measure the electrical impedance between the surface of external electrocardiography electrodes and the skin; it is also typically capable of measuring interference voltages that may be stored on electrodes (i.e., offset voltage) and/or detect faulty lead wires and cables. The device is mainly used to assess the ability of a set of surface (skin) electrodes to conduct bioelectric signals from the skin to the electrodes; it can also measure the impedance of the lead wires and cables from the electrodes to the measuring unit. It is intended to be used by a healthcare provider in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00862186000348 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K993202 | 000 |