Sinus Rinse Kit

Primary DI
00705928003101
Brand
Sinus Rinse Kit
Company
NEILMED PHARMACEUTICALS, INC.
Model
Isotonic, 10ct Packets/Sachets
Device 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.
Published
2023-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KCJApplicator, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCJApplicator, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00705928003101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00705928003101007059280031017059280031010705928003101

GMDN Terms#

Term, Definition table
TermDefinition
Nasal irrigation set, home-useA collection of non-sterile items intended to dispense a solution to penetrate, clear, and clean the nasal passages and sinus cavity for the relief of nasal and sinus symptoms (e.g., nasal congestion, sinus pressure, secretions, nasopharyngeal discharge, encrustations, nasal dryness); it may also be used to create a solution. It typically includes an irrigation bottle/canister, actuator tips and adaptors for various solution-delivery applications, and sometimes packets of sodium-based solutes or prepared solution. It is intended for use in the home. After application, the solution cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
799295915
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00705928603691NeilMed EustachiME82032026-04-27
00705928002043NeilMed Sinus RinsePediatric, 120 Premixed Sachets2023-03-02
00705928003002NeilMed Sinus RinsePediatric, 60 Premixed Sachets2023-03-02
00705928004009NeilMed Sinus Rinse Refill BoxHypertonic, 70 Premixed Packets2023-03-02
00705928014008NeilMed Sinus Rinse KitPediatric, 30ct Packets/Sachets2023-03-02
00705928052000NeilMed Sinus Rinse Refill BoxIsotonic, 50ct Packets/Sachets2023-03-02
00705928652101NeilMed Wound WashWoundWashWW-0NB-48-ENU-USL2020-08-28
00705928001008NeilMed Sinus RinseNeilMed Sinus Rinse Kit 60 Premixed Sachets2022-10-17
00705928000995NeilMed NasogelNasogel TubeNG-6R-96-ENU-USL2022-07-04
00705928045309NeilMed NasogelNasogel SprayGSP30-6R-96-ENU-USL2022-07-04

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