FDA UDI
In Commercial Distribution
🇺🇸 United States
QIJIU
DI: 06973774194449
·
Model: Rectangle 80x130mm
·
Bozhou Rongjian Medical Appliance Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- QIJIU
- Primary DI
- 06973774194449
- Version / Model
- Rectangle 80x130mm
- Company Name
- Bozhou Rongjian Medical Appliance Co., Ltd.
- Labeler DUNS
- 703044684
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2026-04-08
- Public Version
- 1
- Public Version Date
- 2026-04-16
- Public Version Status
- New
- Public Device Record Key
- 98776ac7-50a0-4287-b394-4e573b053be2
Device Description
Self-adhesive Electrode Snap button type
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 06973774194449 | GS1 | ||||
| Unit of Use | 86973774194445 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213879 | 000 |