Disposable bacteria /odour filter

GUDID 07612367031639

Medela AG

Suction system filter, microbial

• Primary Device ID: 07612367031639
• NIH Device Record Key: e724ad79-dbb5-4fbc-8a98-14d28858b059
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable bacteria /odour filter
• Version Model Number: 077.0576
• Company DUNS: 488293218
• Company Name: Medela AG
• Device Count: 10
• 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: false
• 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

Customer Support Contacts

• Phone: +1-877-735-1626
• Email: Info-healthcare@medela.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612367004190 [Primary]
GS1	07612367031639 [Package]; Contains: 07612367004190; Package: [20 Units]; In Commercial Distribution
GS1	07612367051200 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130123

FDA Product Code

• BTA: Pump, Portable, Aspiration (Manual Or Powered)

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: 2016-10-03

Devices Manufactured by Medela AG

• 30020451458916 - Invia Motion 15 Days Kit 10 x 10 cm: 2023-09-11 Invia Motion and Invia Integrated Dressing S Convenience Kit
• 30020451458923 - Invia Motion 15 Days Kit 10 x 15 cm: 2023-09-11 Invia Motion and Invia Integrated Dressing M Convenience Kit
• 30020451458930 - Invia Motion 15 Days Kit 10 x 25 cm: 2023-09-11 Invia Motion and Invia Integrated Dressing L Convenience Kit
• 07612367016131 - Vario 18 AC/DC: 2023-08-15 Powered suction pump
• 07612367016308 - Vario 18 c/i AC/DC: 2023-08-15 Powered suction pump
• 07612367077989 - Invia Integrated Dressing: 2023-07-28 Invia Integrated Dressing - Small (10 X 10)
• 07612367078023 - Invia Integrated Dressing: 2023-07-28 Invia Integrated Dressing – Medium (10 X 15)
• 07612367078030 - Invia Integrated Dressing: 2023-07-28 Invia Integrated Dressing - Large (10 X 25)