TEC 7

GUDID 00840682111744

DATEX-OHMEDA INC

Sevoflurane anaesthesia vaporizer

• Primary Device ID: 00840682111744
• NIH Device Record Key: 0753d08a-1aba-4d08-b867-3d0310ae697f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEC 7
• Version Model Number: VAP SEV 8% EASY-FIL EN B1
• 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 56.66 KiloPascal and 106.66 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682111744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012924

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 7]

• 00840682111454: VAP SEV 8% EASY-FIL EN P1
• 00840682111393: VAP ISO 5% EASY-FIL ES LATIN AMERICA
• 00840682111003: VAP HAL 5% EASY-FIL EN
• 00840682111300: VAP ISO 5% EASY-FIL EN
• 00840682111751: VAP SEV 8% QUIK-FIL EN
• 00840682111744: VAP SEV 8% EASY-FIL EN B1
• 00840682111614: VAP SEV 8% EASY-FIL EN A1
• 00840682111508: VAP SEV 8% EASY-FIL ES LATIN AMERICA
• 00840682111324: VAP HAL 5% EASY-FIL ES LATIN AMERICA
• 00840682111317: VAP SEV 8% EASY-FIL EN