FDA UDI
In Commercial Distribution
🇺🇸 United States
InhwRior
DI: 06978785665124
·
Model: 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
- 06978785665124
- Version / Model
- 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
- 01405454-0c8b-477c-91b2-2353f3027689
Device Description
This product contains primarily sodium chloride (NaCl) in dry, readily soluble form. Dissolve the contents in an appropriate volume of lukewarm water to prepare a nasal irrigation solution. 2.7g/bag
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
- 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 |
|---|---|---|---|---|
| KAR | Irrigator, Sinus | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56700 | Nasal irrigation saline solution | A water-based, salt solution (e.g., isotonic or hypertonic mineral-rich purified sea water) intended to penetrate, clear, clean, and sometimes hydrate the nasal passages and sinus cavity. The solution is typically self-administered (e.g., via a squeeze bottle, glass bottle with a mechanical spray pump, dropper or aerosol) for preventive or symptomatic nasal care. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06978785665124 | GS1 |