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.

• 10887709156620 - Bivona: 2025-05-09 HU25DS70NSC303N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709156736 - Bivona: 2025-05-09 FU25AN40NSF101N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709156750 - Bivona: 2025-05-09 FT25EN35NSA003N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709156767 - Bivona: 2025-05-09 XT25ES50NGF004N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709156774 - Bivona: 2025-05-09 FT25EN45NSA006N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709156781 - Bivona: 2025-05-09 SA25EN80NSC005N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709156811 - Bivona: 2025-05-09 FT25EN45NGF008N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709156828 - Bivona: 2025-05-09 FU25EN45NSF010N Bivona DI: Non-Adjustable-Wired_Non-Sterile