SMARTeZ Pump KVO

GUDID 48859299198116

SMARTeZ Pump KVO 100-0.5-200h

EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED

Elastomeric infusion pump system

• Primary Device ID: 48859299198116
• NIH Device Record Key: f88b2cdf-3821-46b1-a09a-08f5fdea54c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTeZ Pump KVO
• Version Model Number: 498111
• 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	28859299198112 [Primary]
GS1	48859299198116 [Package]; Contains: 28859299198112; 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: 2025-09-19
• Device Publish Date: 2025-09-11

Devices Manufactured by EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED

• 38859299119954 - ProSeal CSTD: 2025-09-19 ProSeal Spike with Additive Port and Seal Tab (DMA Compatible)
• 38859299124118 - ProSeal CSTD: 2025-09-19 ProSeal Non-Vented Bag Spike with ProSeal Injection Site (DMA Compatible)
• 38859299124125 - ProSeal CSTD: 2025-09-19 ProSeal Injector (DMA Compatible)
• 38859299124132 - ProSeal CSTD: 2025-09-19 ProSeal Injector Plus (DMA Compatible)
• 38859299124149 - ProSeal CSTD: 2025-09-19 ProSeal Inline Pump Set (DMA Compatible)
• 38859299124156 - ProSeal CSTD: 2025-09-19 ProSeal Injection Site -Extended MLL (DMA Compatible)
• 38859299130690 - ProSeal CSTD: 2025-09-19 ToxiSeal Vial Adaptor with External Flip Balloon (DMA Compatible) 13 mm Vial
• 38859299130706 - ProSeal CSTD: 2025-09-19 ToxiSeal Vial Adaptor with External Flip Balloon (DMA Compatible) 20 mm Vial