FDA UDI
In Commercial Distribution
🇺🇸 United States
DynaVision Dynamic sEMG Electrodes
DI: 00853818007125
·
Model: PB-50
·
PRECISION BIOMETRICS INC
Product Codes
4
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- DynaVision Dynamic sEMG Electrodes
- Primary DI
- 00853818007125
- Version / Model
- PB-50
- Company Name
- PRECISION BIOMETRICS INC
- Labeler DUNS
- 362997926
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-07
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fc198a70-0720-4eca-9375-4941d8a91ce3
Device Description
Dynamic sEMG Electrodes
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
- 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 |
|---|---|---|---|---|
| KQX | Goniometer, Ac-Powered | Orthopedic | 888.1500 | 1 |
| HCS | Device, Temperature Measurement, Direct Contact, Powered | Neurology | 882.1570 | 2 |
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
| IKN | Electromyograph, Diagnostic | Physical Medicine | 890.1375 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00853818007125 | GS1 | ||||
| Package | 10853818007122 | GS1 | Pouch | 5 | In Commercial Distribution | |
| Package | 00853818007132 | GS1 | Box | 12 | In Commercial Distribution | |
| Package | 00853818007149 | GS1 | Box | 120 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123399 | 000 |