Z-ONE

GUDID 03858894530434

ZAMAR MEDICAL d.o.o.

Circulating-fluid localized thermal/compression therapy system control unit

• Primary Device ID: 03858894530434
• NIH Device Record Key: 7cc969ed-4f21-4e51-8db7-887ac184fe03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z-ONE
• Version Model Number: MG455BC00E
• Company DUNS: 500686107
• Company Name: ZAMAR MEDICAL d.o.o.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	03858894530434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242754

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

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: 2025-06-20
• Device Publish Date: 2025-06-12