Eau de Quinton Pediatric Nasal Hygiene 100 ml

Basic Information

• Brand Name: Eau de Quinton Pediatric Nasal Hygiene 100 ml
• Primary DI: 08437023259016
• Version / Model: PT371
• Company Name: LABORATOIRES QUINTON INTERNATIONAL SL
• Labeler DUNS: 563461441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-24
• Public Version: 1
• Public Version Date: 2023-02-01
• Public Version Status: New
• Public Device Record Key: 004e35a7-b8f2-4aab-b44e-715ef7f82b51

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56700	Nasal irrigation saline solution	A water-based, salt solution (e.g., isotonic or hypertonic mineral-rich purified sea water) intended to penetrate, clear, clean, and sometimes hydrate the nasal passages and sinus cavity. The solution is typically self-administered (e.g., via a squeeze bottle, glass bottle with a mechanical spray pump, dropper or aerosol) for preventive or symptomatic nasal care. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08437023259016	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius