Identity
- Trade Name
- NeilMed Sinus Rinse FDA UDI
- Generic Name
- Nasal irrigation set, home-use FDA UDI
- Device Name
- 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 Pediatric Sinus Rinse Kit comes with 120mL bottle and premixed packets containing a mixture of sodium chloride. The concentration of the salt mixture in the Pediatric Sinus Rinse Packets/Sachets produces the same solution as the isotonic sinus rinse packets/sachets, but the net content in the packets/sachets is measured for a mixing with a lower water volume for irrigation. FDA UDI
- Model / Reference
- Pediatric, 60 Premixed Sachets FDA UDI
- 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 Pediatric Sinus Rinse Kit comes with 120mL bottle and premixed packets containing a mixture of sodium chloride. The concentration of the salt mixture in the Pediatric Sinus Rinse Packets/Sachets produces the same solution as the isotonic sinus rinse packets/sachets, but the net content in the packets/sachets is measured for a mixing with a lower water volume for irrigation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00705928003002 FDA UDI
- FDA Product Code
- KCJ FDA UDI
- GMDN Term
- Nasal irrigation set, home-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.5220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nasal irrigation set, home-use
NeilMed Sinus Rinse by NeilMed Pharmaceuticals Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NeilMed Pharmaceuticals Inc.
Sources (1)
- FDA UDI fd159c36-768b-4854-8852-cb1673894237 33 fields · synced Jun 6, 2026