Aisys

GUDID 00195278588128

AISYS CS2 WITH ET CONTROL

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

• Primary Device ID: 00195278588128
• NIH Device Record Key: d5185995-6646-418c-a548-fe04f1def1f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aisys
• Version Model Number: CS2 WITH ET CONTROL
• 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: false
• OTC Over-The-Counter: false

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 105.66 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 105.66 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 105.66 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 105.66 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 105.66 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 105.66 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 105.66 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 105.66 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 105.66 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278588128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170872

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: 2022-07-29
• Device Publish Date: 2022-07-21

On-Brand Devices [Aisys]

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