TEC 6 PLUS

GUDID 00840682112659

DATEX-OHMEDA INC

Desflurane anaesthesia vaporizer

• Primary Device ID: 00840682112659
• NIH Device Record Key: 15a3a142-932a-4c13-9df0-99f4dd226edd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEC 6 PLUS
• Version Model Number: VAP DES 220/240V EN
• Company DUNS: 129501685
• Company Name: DATEX-OHMEDA INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682112659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000275

FDA Product Code

• CAD: VAPORIZER, ANESTHESIA, NON-HEATED

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: 2016-06-01

On-Brand Devices [TEC 6 PLUS]

• 00840682112536: VAP DES 120V USA
• 00840682112789: VAP DES 120V ES
• 00840682112659: VAP DES 220/240V EN