eZSURE™

GUDID 38859299136135

Empty Fluid Container 100 ml Max Capacity

EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED

Intravenous administration bag/bottle

• Primary Device ID: 38859299136135
• NIH Device Record Key: d8e8388f-6075-449f-a32a-ea3298a2bb44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eZSURE™
• Version Model Number: 426130
• Company DUNS: 662213220
• Company Name: EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18859299136131 [Primary]
GS1	38859299136135 [Package]; Contains: 18859299136131; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241442

FDA Product Code

• KPE: Container, I.V.

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-19
• Device Publish Date: 2025-09-11

On-Brand Devices [eZSURE™]

• 38859299136111: eZSURE™ Empty Fluid Container 500 ml Max Capacity
• 38859299136081: eZSURE™ Empty Fluid Container 500 ml Max Capacity
• 38859299136074: eZSURE™ Empty Fluid Container 250 ml Max Capacity
• 38859299136067: eZSURE™ Empty Fluid Container 100 ml Max Capacity
• 38859299136043: eZSURE™ Empty Fluid Container 250 ml Max Capacity
• 38859299136036: eZSURE™ Empty Fluid Container 100 ml Max Capacity
• 38859299136173: Tamper Evident Cap
• 38859299136159: Empty Fluid Container 500 ml Max Capacity (ProSeal Injection Site Fill Port)
• 38859299136142: Empty Fluid Container 250 ml Max Capacity
• 38859299136135: Empty Fluid Container 100 ml Max Capacity