← Back to catalogue

NeilMed Sinus Rinse Refill Box

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 5003S-BRO-WLDModel 705928052000

by NeilMed Pharmaceuticals Inc.

Identity

Trade Name
NeilMed Sinus Rinse 50 Premixed Sachets EUDAMED
NeilMed Sinus Rinse Refill Box FDA UDI
Generic Name
Nasal irrigation set, home-use FDA UDI
Device Name
NeilMed Sinus Rinse 50 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 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
705928052000 EUDAMED
5003S-BRO-WLD EUDAMED
Isotonic, 50ct 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
00705928052000 EUDAMEDFDA UDI
Basic UDI-DI
B-00705928052000 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
NeilMed Pharmaceuticals Inc.

Sources (2)

  • FDA UDI 7ae79fcc-d4bf-46c1-ac63-c50f25f3e036 33 fields · synced Jun 18, 2026
  • EUDAMED 9a2fc1f0-0127-4c7f-aa33-ea99877b52bf 61 fields · synced Jun 18, 2026