Apex

Basic Information

• Brand Name: Apex
• Primary DI: 00076855700365
• Version / Model: 70036
• Company Name: COMPASS HEALTH BRANDS CORP.
• Labeler DUNS: 827221698
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-08
• Public Version: 2
• Public Version Date: 2023-09-04
• Public Version Status: Update
• Public Device Record Key: 85490462-4e88-4200-8ba7-20b303219b40

Device Description

Baby Ear Syringe

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
KYW	Container, Liquid Medication, Graduated	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36279	Medication cartridge syringe, needleless, single-use	A sterile device designed to be used in conjunction with a hermetically-sealed glass cartridge containing medication (not included) to propel the contents of the cartridge across the skin (transcutaneous delivery) and into the subcutaneous tissue (needleless) when used in combination with an injector (not included). It consists of a breech-loading barrel, plunger and specialized nozzle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30076855700366	GS1		72	In Commercial Distribution
Primary	00076855700365	GS1

Customer Contacts

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