Procedure Pack

Basic Information

• Brand Name: Procedure Pack
• Primary DI: 05060498950343
• Version / Model: ZX2000
• Company Name: EUROPLAZ TECHNOLOGIES LTD
• Labeler DUNS: 220440619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-31
• Public Version: 1
• Public Version Date: 2026-02-09
• Public Version Status: New
• Public Device Record Key: 2307c1ae-0f9e-40c8-a276-4024c4f2c03f

Device Description

ZX1000 Mixing Bottle & Dosing Cup + Two Rovipharm 26489151 Oral Dosing Syringes

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PXA	Oral Administration Set	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45726	Medicine cup, reusable	A cup specially designed for administering medicine to patients or disabled persons. It will typically be made of stainless steel or durable plastic materials 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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15060498950340	GS1	Cardboard carton	4	In Commercial Distribution
Primary	05060498950343	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius