Medfusion

GUDID 10610586031823

ICU MEDICAL, INC.

Suction system filter, microbial

• Primary Device ID: 10610586031823
• NIH Device Record Key: dd865a58-ae66-47d8-9a2a-ad7a988f37c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medfusion
• Version Model Number: 3000CAL
• Company DUNS: 118380146
• Company Name: ICU MEDICAL, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10610586031823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982640

FDA Product Code

• FRN: Pump, infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2025-04-16
• Device Publish Date: 2016-11-16

Devices Manufactured by ICU MEDICAL, INC.

• 10887709171098 - Bivona: 2025-10-07 FP25IN45NSF230N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709171104 - Bivona: 2025-10-07 FP25IN45NSF229N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709171111 - Bivona: 2025-10-07 FT25IN30NGE228N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709171128 - Bivona: 2025-10-07 FT25IN35NGE227N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709171135 - Bivona: 2025-10-07 ST25IN55NSA225N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709171142 - Bivona: 2025-10-07 FU25IN35NGE224N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709171159 - Bivona: 2025-10-07 FU25IN40NGE223N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709171166 - Bivona: 2025-10-07 FU25IN40NGE221S Bivona DI: Non-Adjustable-Wired-Sterile