Aisys

GUDID 00840682102292

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: 00840682102292
• NIH Device Record Key: b59b02ee-c17e-4e53-8347-30496519ff06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aisys
• 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(999)999-9999
• 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
• Phone: +1(800)345-2700
• Email: xx@xx.xx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682102292 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132530

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: 5
• Public Version Date: 2020-02-12
• Device Publish Date: 2015-09-23

On-Brand Devices [Aisys]

• 00840682102292: CS2
• 00195278588128: AISYS CS2 WITH ET CONTROL