Apex

Basic Information

• Brand Name: Apex
• Primary DI: 00635515992665
• Version / Model: 60105QC
• Company Name: COMPASS HEALTH BRANDS CORP.
• Labeler DUNS: 827221698
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-15
• Public Version: 2
• Public Version Date: 2023-09-01
• Public Version Status: Update
• Public Device Record Key: c077f672-e3eb-4b2d-a194-7959363c3e76

Device Description

MEDICINE SPOON/SUPER DROPPER BLISTERED QUALITY CHOICE

Device Characteristics

• Single Use: No
• 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: 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
KCM	Dropper, Ent	Ear, Nose, Throat	874.5220	1
KYX	Dispenser, Liquid Medication	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35845	Medicine spoon, reusable	A device used for orally dosing/portioning/serving medicine to a recipient, e.g., a patient or person with a disability. It will typically be designed to facilitate giving different quantities and to show these in defined level markings. This is a reusable device.	No	Active
12506	Oral medicine dropper	A device designed for aspirating a small volume of liquid medicine so that it can be dispensed in single drops into a patient's mouth, typically an infant or small child. It is typically designed as a hollow tube, open at both ends, with an aspiration bulb attached to the proximal end and a narrow opening at the distal end. It is usually made of glass or plastic with a rubber teat. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30041520876479	GS1		144	In Commercial Distribution
Primary	00635515992665	GS1

Customer Contacts

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