Dominant Flex

GUDID 07612367088138

Powered suction pump 101046566

Medela AG

Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump Surgical suction pump

• Primary Device ID: 07612367088138
• NIH Device Record Key: e735083f-f1aa-47cb-af6c-368b8679caff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dominant Flex
• Version Model Number: 101046566
• 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	07612367088138 [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