FDA UDI
In Commercial Distribution
🇺🇸 United States
BioWave Noninvasive Velcro Backed Electrodes - B-Set
DI: 00859911006607
·
Model: BIOWRAP-PADS
·
BIOWAVE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioWave Noninvasive Velcro Backed Electrodes - B-Set
- Primary DI
- 00859911006607
- Version / Model
- BIOWRAP-PADS
- Company Name
- BIOWAVE CORPORATION
- Labeler DUNS
- 005759084
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-07
- Public Version
- 1
- Public Version Date
- 2023-08-15
- Public Version Status
- New
- Public Device Record Key
- 8386ddc9-95ea-4c3f-8cb6-337a63f8b5d5
Device Description
BioWave Noninvasive Velcro Backed Electrodes - B-Set - 1 pair - for use with BioWave BLUE BioWraps
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
- No
- 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 |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65318 | Transcutaneous electrical stimulation electrode, reusable | An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859911006607 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203158 | 000 |