Infinium Medical Inc.

GUDID 00852087007898

INFINIUM MEDICAL, INC.

Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose Anaesthesia workstation, general-purpose

• Primary Device ID: 00852087007898
• NIH Device Record Key: 7a66e51f-ac77-40cb-83ee-287268f2e537
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinium Medical Inc.
• Version Model Number: OBA MRI Compatible Anesthesia Machine
• Company DUNS: 037504771
• Company Name: INFINIUM MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852087007898 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012446

FDA Product Code

• BSZ: Gas-Machine, Anesthesia

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: 2024-05-14
• Device Publish Date: 2024-05-06

On-Brand Devices [Infinium Medical Inc.]

• 00852087007898: OBA MRI Compatible Anesthesia Machine
• 00852087007881: OBA Anesthesia Machine