FDA UDI In Commercial Distribution 🇺🇸 United States

AUVON

DI: 06971292002413 · 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
06971292002413
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
2023-02-21
Public Version
1
Public Version Date
2023-03-01
Public Version Status
New
Public Device Record Key
047028ef-8338-4f5c-bd1d-99b916732e5b

Device Description

The self-adhesive electrode is intended to be used to apply electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS (Transcutaneous Electrical Nerve Stimulation) EMS (Electrical Muscular Stimulation)

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
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GXY Electrode, Cutaneous

GMDN Terms

Code Name
35995 Transcutaneous electrical stimulation electrode, single-use

Identifiers

Type ID
Package 16971292002410
Primary 06971292002413