FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 06970341670283
·
Model: CWN2505
·
GMDASZ manufacturing Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 06970341670283
- Version / Model
- CWN2505
- Company Name
- GMDASZ manufacturing Co., Ltd.
- Labeler DUNS
- 529401134
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-26
- Public Version
- 4
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- bd308d1f-ea3b-4faf-b6b1-ed64ab030fbe
Device Description
CWN2505, electrode pad, 5x5cm, tan cloth, GMDASZ Mfg
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 | 00697034167740 | GS1 | paper carton | 630 | In Commercial Distribution | |
| Primary | 06970341670283 | GS1 | ||||
| Package | 06970341677336 | GS1 | paper carton | 600 | In Commercial Distribution | |
| Package | 06970341677305 | GS1 | paper carton | 420 | In Commercial Distribution | |
| Package | 06970341674434 | GS1 | PE bag | 2 | In Commercial Distribution | |
| Package | 06970341674410 | GS1 | PE bag | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160138 | 000 |