Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00810077211625
• Version / Model: PL M-CUPx2
• Catalog Number: PL M-CUPx2
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2021-10-15
• Public Version: 1
• Public Version Date: 2021-10-25
• Public Version Status: New
• Public Device Record Key: 4359c7a3-4c73-4fcd-afed-8ec7afd870d2

Device Description

Plastic Medicine Cups, 1 OZ [Pack of200]

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: Yes
• 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
KYW	CONTAINER, LIQUID MEDICATION, GRADUATED	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12505	Medicine cup, single-use	A cup specially designed for administering medicine to patients or disabled persons. It is made of disposable plastic and will typically have graduated markings to facilitate providing specific doses of medication. It may be used both for tablets and fluids. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850025452632	GS1
Primary	00810077211625	GS1

Customer Contacts

• Phone: [phone] ext. 204
• Email: [email protected]