Nanodropper B14

Basic Information

• Brand Name: Nanodropper B14
• Primary DI: 00860003576120
• Version / Model: B14
• Catalog Number: LUNA-B14
• Company Name: NANODROPPER, INC.
• Labeler DUNS: 081371550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-22
• Public Version: 1
• Public Version Date: 2024-10-30
• Public Version Status: New
• Public Device Record Key: 489c3a41-6369-4848-9e61-3860277f8479

Device Description

The Nanodropper B14 is an eye drop bottle adaptor. The Nanodropper B14 is for single-bottle use only.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYX	Dispenser, Liquid Medication	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64886	Eye dropper bottle nozzle adaptor	A nozzle extension intended to be fitted to an eye dropper bottle to decrease the droplet size of an eye irrigation/treatment solution during self-administration. It is intended to be used for the expected duration of the content of a single bottle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00860003576137	GS1	Case	20	In Commercial Distribution
Primary	00860003576120	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]