NeilMed Sinus Rinse Refill Box

GUDID 00705928004009

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.

NEILMED PHARMACEUTICALS, INC.

Nasal irrigation set, home-use

• Primary Device ID: 00705928004009
• NIH Device Record Key: 3e04400f-1d11-41ef-b3f0-27c53326049d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeilMed Sinus Rinse Refill Box
• Version Model Number: Hypertonic, 70 Premixed Packets
• 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	00705928004009 [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 Refill Box]

• 00705928052000: Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit v
• 00705928004009: Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit v