UnoDose Metered-Dose Topical Applicator

Basic Information

• Brand Name: UnoDose Metered-Dose Topical Applicator
• Primary DI: G5511000031
• Version / Model: 25-Pack Pink
• Catalog Number: 1000-03
• Company Name: Reflex Medical Corp.
• Labeler DUNS: 146548271
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-29
• Public Version: 1
• Public Version Date: 2023-10-09
• Public Version Status: New
• Public Device Record Key: 35fc556d-43ba-4255-9d08-ccea03f4f1c3

Device Description

The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for application to the skin. It also serves as a mixing container for compounding creams and gels with electronic mortar and pestle (EMP) systems.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

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
64370	Home-use transdermal medication applicator	A non-powered, non-absorbent, hand-held device designed to be used in the home for the topical application of a semi-solid transdermal medication (e.g., hormone gel, medicated cream) [not included] to the skin surface; it is intended to prevent contact between the medicated substance and the patient’s hands to reduce the risk of medication exposure in the environment. It is typically in the form of a cylinder with a smooth head on which the substance is dispensed prior to skin application. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G5511000031	HIBCC

Customer Contacts

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