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NeilMed Sinus Rinse

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 5003S-BRO-WLDModel 705928002043

by NeilMed Pharmaceuticals Inc.

Identity

Trade Name
NeilMed Sinus Rinse 120 Premixed Sachets EUDAMED
NeilMed Sinus Rinse FDA UDI
Generic Name
Nasal irrigation set, home-use FDA UDI
Device Name
NeilMed Sinus Rinse 120 Premixed Sachets EUDAMED
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
705928002043 EUDAMED
5003S-BRO-WLD EUDAMED
Pediatric, 120 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
00705928002043 EUDAMEDFDA UDI
Basic UDI-DI
B-00705928002043 EUDAMED
FDA Product Code
KCJ FDA UDI
EMDN Code
Q030103 NASAL IRRIGATION SOLUTIONS EUDAMED
GMDN Term
Nasal irrigation set, home-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
874.5220 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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 — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Nasal irrigation set, home-use.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NeilMed Pharmaceuticals Inc.

Sources (2)

  • FDA UDI c12bee54-b7e7-4a93-93e6-c4c90e85b9b9 33 fields · synced Jun 19, 2026
  • EUDAMED 137f5f50-8be0-45cb-b3ae-8b70a2a5178b 61 fields · synced Jun 19, 2026