Fabius GS premium

GUDID 04048675041467

Drägerwerk AG & Co. KGaA

Anaesthesia workstation, general-purpose

• Primary Device ID: 04048675041467
• NIH Device Record Key: 9951bafd-ffc8-463e-a304-0af8c0ae9e1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fabius GS premium
• Version Model Number: 8607000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048675041467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042419

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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• 04048675715252 - Anesth Set Flex 160 (BagCone OD22): 2024-10-16
• 04048675035695 - Hook ring LITESTAR,15mm,conn.: 2024-10-10
• 04048675035701 - Hook ring LITESTAR,22mm,conn.: 2024-10-10
• 04048675246558 - Babytherm 8010 System: 2024-08-23
• 04048675703853 - HME HumidStar 2 Plus Luer-Lock: 2024-07-30
• 04048675540137 - Disposable Handle Polaris, Single: 2024-07-18