Fabius OS

GUDID 04048675398240

Drägerwerk AG & Co. KGaA

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: 04048675398240
• NIH Device Record Key: cd4c5b89-49bb-4c97-bf0d-9854d8afc98e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fabius OS
• Version Model Number: 8608300
• Company DUNS: 315578914
• Company Name: Drägerwerk AG & Co. KGaA
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com
• Phone: +494518820
• Email: info@draeger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048675398240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011404

FDA Product Code

• BSZ: Gas-Machine, Anesthesia

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

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• 04048675697718 - SelfTestLung: 2023-09-07
• 04048675389583 - VentStar humidifier chamber (N): 2023-07-31
• 04048675411758 - VentStar Helix heated (N) Plus: 2023-07-31