Avance

GUDID 00840682102322

DATEX-OHMEDA 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

• Primary Device ID: 00840682102322
• NIH Device Record Key: c3604119-4326-4e8d-a116-d7f9d0563614
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avance
• Version Model Number: CS2
• Company DUNS: 129501685
• Company Name: DATEX-OHMEDA INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx
• Phone: +1(800)345-2700
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 56.66 KiloPascal and 106.66 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 56.66 KiloPascal and 106.66 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 56.66 KiloPascal and 106.66 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 56.66 KiloPascal and 106.66 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 56.66 KiloPascal and 106.66 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 56.66 KiloPascal and 106.66 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 56.66 KiloPascal and 106.66 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 56.66 KiloPascal and 106.66 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 56.66 KiloPascal and 106.66 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 56.66 KiloPascal and 106.66 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 56.66 KiloPascal and 106.66 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 56.66 KiloPascal and 106.66 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 56.66 KiloPascal and 106.66 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682102322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123125

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: 4
• Public Version Date: 2018-09-13
• Device Publish Date: 2015-09-23

Devices Manufactured by DATEX-OHMEDA INC

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• 00840682145596 - Carestation 750: 2023-04-12 CARESTATION 750 A1
• 00840682146425 - Carestation 750c: 2023-04-12 CARESTATION 750c A1
• 00840682143684 - IV POLE ASSY 12 IN: 2022-12-14 IV POLE 12 IN
• 00840682143691 - ROTATING IV POLE: 2022-12-14 ROTATING IV POLE
• 00840682143707 - IV POLE ASSY 24 IN: 2022-12-14 IV POLE 24 IN
• 00195278579157 - ET CONTROL OPTION: 2022-07-29 ET CONTROL OPTION