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NeilMed Sinus Rinse Refill Box

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 5003S-BRO-WLDModel 705928004009

by NeilMed Pharmaceuticals Inc.

Identity

Trade Name
NeilMed Sinus Rinse Extra Strength (Hypertonic) 70 Premixed Sachets EUDAMED
NeilMed Sinus Rinse Refill Box FDA UDI
Generic Name
Nasal irrigation set, home-use FDA UDI
Device Name
NeilMed Sinus Rinse Extra Strength (Hypertonic) 70 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 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. FDA UDI
Model / Reference
705928004009 EUDAMED
5003S-BRO-WLD EUDAMED
Hypertonic, 70 Premixed Packets 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 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. FDA UDI

Identifiers

Primary DI / UDI-DI
00705928004009 EUDAMEDFDA UDI
Basic UDI-DI
B-00705928004009 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 Refill Box 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 3e04400f-1d11-41ef-b3f0-27c53326049d 33 fields · synced Jul 24, 2026
  • EUDAMED a85759aa-f4e0-419e-9ef4-687bed31c549 61 fields · synced Jul 24, 2026