Sinus Rinse Kit

GUDID 00705928003101

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.

NEILMED PHARMACEUTICALS, INC.

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Primary Device ID00705928003101
NIH Device Record Keyb69d1a97-b507-4be2-b6ef-2d2aa50177da
Commercial Distribution StatusIn Commercial Distribution
Brand NameSinus Rinse Kit
Version Model NumberIsotonic, 10ct Packets/Sachets
Company DUNS799295915
Company NameNEILMED PHARMACEUTICALS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100705928003101 [Primary]

FDA Product Code

KCJApplicator, Ent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-10
Device Publish Date2023-03-02

Devices Manufactured by NEILMED PHARMACEUTICALS, INC.

00705928002043 - NeilMed Sinus Rinse2023-03-10 Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit variants also contain a bottle as
00705928003002 - NeilMed Sinus Rinse2023-03-10 Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit variants also contain a bottle as
00705928003101 - Sinus Rinse Kit2023-03-10Sinus 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.
00705928003101 - Sinus Rinse Kit2023-03-10 Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit variants also contain a bottle as
00705928004009 - NeilMed Sinus Rinse Refill Box2023-03-10 Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit variants also contain a bottle as
00705928014008 - NeilMed Sinus Rinse Kit2023-03-10 Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit variants also contain a bottle as
00705928052000 - NeilMed Sinus Rinse Refill Box2023-03-10 Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit variants also contain a bottle as
00705928001008 - NeilMed Sinus Rinse2022-10-25 Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit variants also contain a bottle as
00705928000995 - NeilMed Nasogel2022-07-12 Nasogel provide moisturize to hydrate and lubricate dry and irritated nasal passages caused by dry climate and indoor heat. It h

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