FDA UDI
In Commercial Distribution
🇺🇸 United States
InhwRior
DI: 06978785665131
·
Model: JQ-S14U-XBY
·
Shenzhen Yuechuan trade Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- InhwRior
- Primary DI
- 06978785665131
- Version / Model
- JQ-S14U-XBY
- Company Name
- Shenzhen Yuechuan trade Co., Ltd.
- Labeler DUNS
- 450549961
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-08
- Public Version
- 1
- Public Version Date
- 2025-12-16
- Public Version Status
- New
- Public Device Record Key
- 14d1d7ea-af70-4657-9952-f6229cd4a705
Device Description
This combined product is designed for use in the management of conditions such as allergic rhinitis, sinusitis, nasal congestion due to colds or flu, and for post-operative care. Irrigator:Water Tank Capacity: 200ml Rated Voltage: DC 3.7V Nasal Rinse Salt:Net weight 1.8g x 30 sachets
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KMA | Irrigator, Powered Nasal | Ear, Nose, Throat | 874.5550 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44845 | Nasal irrigation set, home-use | A collection of non-sterile items intended to dispense a solution to penetrate, clear, and clean the nasal passages and sinus cavity for the relief of nasal and sinus symptoms (e.g., nasal congestion, sinus pressure, secretions, nasopharyngeal discharge, encrustations, nasal dryness); it may also be used to create a solution. It typically includes an irrigation bottle/canister, actuator tips and adaptors for various solution-delivery applications, and sometimes packets of sodium-based solutes or prepared solution. It is intended for use in the home. After application, the solution cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06978785665131 | GS1 |