Aestiva

GUDID 00840682102339

DATEX-OHMEDA INC

Anaesthesia workstation, general-purpose

• Primary Device ID: 00840682102339
• NIH Device Record Key: b5e08c50-2ef1-494a-8cd1-bb5b82a56546
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aestiva
• Version Model Number: MRI
• Company DUNS: 129501685
• Company Name: DATEX-OHMEDA INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *magnetic fringe field less than or equal to 300 gauss

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682102339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050055

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: 2015-09-23

On-Brand Devices [Aestiva]

• 00840682102339: MRI
• 00840682102308: 7900