Procedure Pack

GUDID 15060498950340

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

EUROPLAZ TECHNOLOGIES LTD

Medicine cup, reusable

• Primary Device ID: 15060498950340
• NIH Device Record Key: 2307c1ae-0f9e-40c8-a276-4024c4f2c03f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Pack
• Version Model Number: ZX2000
• Company DUNS: 220440619
• Company Name: EUROPLAZ TECHNOLOGIES LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060498950343 [Primary]
GS1	15060498950340 [Package]; Contains: 05060498950343; Package: Cardboard carton [4 Units]; In Commercial Distribution

FDA Product Code

• PXA: Oral Administration Set

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-09
• Device Publish Date: 2026-01-31

Devices Manufactured by EUROPLAZ TECHNOLOGIES LTD

• 15060498950333 - Dosing System: 2026-02-09 Mixing Bottle & Dosing Cup
• 15060498950340 - Procedure Pack: 2026-02-09ZX1000 Mixing Bottle & Dosing Cup + Two Rovipharm 26489151 Oral Dosing Syringes
• 15060498950340 - Procedure Pack: 2026-02-09 ZX1000 Mixing Bottle & Dosing Cup + Two Rovipharm 26489151 Oral Dosing Syringes