Aladin2 1100-9032-000

GUDID 00840682100250

DATEX-OHMEDA INC

Sevoflurane anaesthesia vaporizer

• Primary Device ID: 00840682100250
• NIH Device Record Key: d95097f3-eda4-4bfe-8c18-4dd5485db856
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aladin2
• Version Model Number: SEV QUIK-FIL
• Catalog Number: 1100-9032-000
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682100250 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-23

On-Brand Devices [Aladin2]

• 00840682123990: SEV CLOSED-FILL
• 00840682123983: SEV CLOSED-FILL
• 00840682100298: SEV EASY-FIL A
• 00840682100281: DES SAF-FIL B
• 00840682100274: ENF EASY-FIL
• 00840682100267: SEV EASY-FIL
• 00840682100250: SEV QUIK-FIL
• 00840682100243: ISO EASY-FIL
• 00840682100236: SEV QUIK-FIL A
• 00840682100229: DES FIXED-FIL
• 00840682100212: SEV EASY-FIL B
• 00840682100205: DES SAF-FIL