FDA UDI
In Commercial Distribution
🇺🇸 United States
AUVON
DI: 06971292006879
·
Model: EB1520
·
Shenzhen Yuwen E-Commerce Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AUVON
- Primary DI
- 06971292006879
- Version / Model
- EB1520
- Company Name
- Shenzhen Yuwen E-Commerce Co., Ltd.
- Labeler DUNS
- 544559614
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-13
- Public Version
- 1
- Public Version Date
- 2024-08-21
- Public Version Status
- New
- Public Device Record Key
- d1f0b159-2f4e-4c33-bdb8-1eb864beb18b
Device Description
The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 35995 | Transcutaneous electrical stimulation electrode, single-use | 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16971292006876 | GS1 | 80 | In Commercial Distribution | ||
| Primary | 06971292006879 | GS1 |
Customer Contacts
- Phone
- +1(678)829-7256
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192568 | 000 |