SMARTeZ Pump KVO

GUDID 48859299198130

SMARTeZ Pump KVO 50-0.5-100h

EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED

Elastomeric infusion pump system

• Primary Device ID: 48859299198130
• NIH Device Record Key: eadd5a99-fcc8-4ce8-9121-d7ef49792c12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTeZ Pump KVO
• Version Model Number: 498131
• 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	28859299198136 [Primary]
GS1	48859299198130 [Package]; Contains: 28859299198136; Package: Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242152

FDA Product Code

• MEB: Pump, Infusion, Elastomeric

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: 2026-02-11
• Device Publish Date: 2026-02-03

On-Brand Devices [SMARTeZ Pump KVO]

• 48859299198116: SMARTeZ Pump KVO 100-0.5-200h
• 28859299198143: SMARTeZ Pump KVO 50-1-50h
• 48859299198130: SMARTeZ Pump KVO 50-0.5-100h
• 48859299198123: SMARTeZ Pump KVO 100-1-100h