FDA UDI
In Commercial Distribution
🇺🇸 United States
Jiajian
DI: 06972011716000
·
Model: 50*130mm
·
Wuxi Jiajian Medical Instrument Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Jiajian
- Primary DI
- 06972011716000
- Version / Model
- 50*130mm
- Company Name
- Wuxi Jiajian Medical Instrument Co.,Ltd.
- Labeler DUNS
- 529966489
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-15
- Public Version
- 1
- Public Version Date
- 2019-08-23
- Public Version Status
- New
- Public Device Record Key
- d54f0da4-21e3-4b47-9278-04a747fbeb94
Device Description
Flexible and easy to fit electrode can be applied to every contour of the human body. You can use the electrodes many times because of its reliable long lasting gel. 2 Electrodes in sealed foil pouch.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 61170 | Electrical probe/electrode conductive pad | A small, non-sterile device designed to facilitate electrical conduction between an electrical stimulation probe or electrode and the skin. It is typically contoured to fit on a particular type of probe/electrode and is made of an absorbent material (e.g., felt) that may be soaked in a conduction fluid. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26972011716004 | GS1 | Carton | 20 | In Commercial Distribution | |
| Package | 16972011716007 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 06972011716000 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090198 | 000 |