NeilMed Sinus Rinse

GUDID 00705928002043

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.

NEILMED PHARMACEUTICALS, INC.

Nasal irrigation set, home-use

• Primary Device ID: 00705928002043
• NIH Device Record Key: c12bee54-b7e7-4a93-93e6-c4c90e85b9b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeilMed Sinus Rinse
• Version Model Number: Pediatric, 120 Premixed Sachets
• Company DUNS: 799295915
• Company Name: NEILMED PHARMACEUTICALS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00705928002043 [Primary]

FDA Product Code

• KCJ: Applicator, Ent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-10
• Device Publish Date: 2023-03-02

On-Brand Devices [NeilMed Sinus Rinse]

• 00705928001008: Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit v
• 00705928003002: Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit v
• 00705928002043: Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit v