NeilMed Sinus Rinse Refill Box
Basic Information
- Brand Name
- NeilMed Sinus Rinse Refill Box
- Primary DI
- 00705928004009
- Version / Model
- Hypertonic, 70 Premixed Packets
- Company Name
- NEILMED PHARMACEUTICALS, INC.
- Labeler DUNS
- 799295915
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-02
- Public Version
- 1
- Public Version Date
- 2023-03-10
- Public Version Status
- New
- Public Device Record Key
- 3e04400f-1d11-41ef-b3f0-27c53326049d
Device Description
Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit variants also contain a bottle assembly (bottle, cap and tube that is affixed to the cap). The packets/sachets contain a defined ratio of sodium chloride and sodium bicarbonate that provides a pH balanced isotonic, solution the resulting saline solution is squirted through a bottle assembly designed at NeilMed Products, Inc. The Hypertonic Sinus Rinse is an extra strength saline solution, which delivers over twice the concentration of saline as Isotonic Sinus Rinse Products. It comes with premixed packets/sachets containing a mixture of sodium chloride and sodium bicarbonate sold in an individual box. After mixing one packet/sachet with 240mL of water in 240mL bottle, a 1.8% saline solution is produced. After mixing one packet/sachet with 480mL of water in 480mL bottle, a 0.9% saline solution is produced.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| KCJ | Applicator, Ent | Ear, Nose, Throat | 874.5220 | 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 | 00705928004009 | GS1 |