Sinus Rinse Kit

FDA UDI

Class I (US FDA UDI)

by NeilMed Pharmaceuticals Inc.

Identity

Trade Name: Sinus Rinse Kit 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 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. FDA UDI
Model / Reference: Isotonic, 10ct Packets/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 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00705928003101 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

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

Sinus Rinse Kit by NeilMed Pharmaceuticals Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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NeilMed Sinus Rinse — NeilMed Pharmaceuticals Inc. · Class I
NeilMed Sinus Rinse — NeilMed Pharmaceuticals Inc. · Class I
NeilMed Sinus Rinse Refill Box — NeilMed Pharmaceuticals Inc. · Class I

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 b69d1a97-b507-4be2-b6ef-2d2aa50177da 33 fields · synced May 30, 2026