Dominant Flex

GUDID 07612367088145

Powered suction pump

Medela AG

Surgical suction pump

• Primary Device ID: 07612367088145
• NIH Device Record Key: df673f36-bf4c-48e8-98de-58c75e99063c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dominant Flex
• Version Model Number: 101046567
• Company DUNS: 488293218
• Company Name: Medela AG
• 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: 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
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com
• Phone: +1-877-735-1626
• Email: info-healthcare@medela.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612367088145 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-10
• Device Publish Date: 2024-05-31

On-Brand Devices [Dominant Flex]

• 07612367088145: Powered suction pump
• 07612367088138: Powered suction pump 101046566