NeilMed Sinus Rinse Refill Box (UDI Isotonic, 50ct Packets/Sachets)
Manufactured by NEILMED PHARMACEUTICALS, INC.
Device Regulatory Overview
The NeilMed Sinus Rinse Refill Box (Model/Catalog Number: Isotonic, 50ct Packets/Sachets) is a medical device manufactured by NEILMED PHARMACEUTICALS, INC.. This product is indexed under FDA Product Code / Category Classification KCJ within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Isotonic, 50ct Packets/Sachets
- Product Code / EMDN
- KCJ
- 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 regular Isotonic Sinus Rinse packets/sachets have salt concentration with a tonicity close to that of plasma or serum. The Isotonic Sinus Rinse Kit comes with a 240mL bottle premixed Packets/sachets containing a mixture of sodium chloride and sodium bicarbonate. This produces 0.9 % saline solution on mixing one packet with 240mL of water. The packets/sachets also come in an individual box
- Database Sync Date
- 2026-08-09 09:04:15
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of NeilMed Sinus Rinse Refill Box?
The registered manufacturer of record for NeilMed Sinus Rinse Refill Box is NEILMED PHARMACEUTICALS, INC..
What is the Primary UDI-DI identifier for NeilMed Sinus Rinse Refill Box?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Isotonic, 50ct Packets/Sachets.
What classification code is assigned to this device?
This device is registered under product classification code KCJ.
Similar Classification Devices (KCJ)
Other Devices by NEILMED PHARMACEUTICALS, INC.
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