Freestyle Flex

GUDID 07612367071918

Breast Pump

Medela AG

Breast pump, electric

• Primary Device ID: 07612367071918
• NIH Device Record Key: 38a9baa2-a29a-428e-b03d-91b40ad527a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freestyle Flex
• Version Model Number: 101037980
• Company DUNS: 488293218
• Company Name: Medela AG
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-435-8316
• Email: custom-er.service@medela.com
• Phone: 1-800-435-8316
• Email: custom-er.service@medela.com
• Phone: 1-800-435-8316
• Email: custom-er.service@medela.com
• Phone: 1-800-435-8316
• Email: custom-er.service@medela.com
• Phone: 1-800-435-8316
• Email: custom-er.service@medela.com
• Phone: 1-800-435-8316
• Email: custom-er.service@medela.com
• Phone: 1-800-435-8316
• Email: custom-er.service@medela.com
• Phone: 1-800-435-8316
• Email: custom-er.service@medela.com
• Phone: 1-800-435-8316
• Email: custom-er.service@medela.com
• Phone: 1-800-435-8316
• Email: custom-er.service@medela.com
• Phone: 1-800-435-8316
• Email: custom-er.service@medela.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612367065863 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	07612367071918 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191653

FDA Product Code

• HGX: Pump, Breast, 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: 2019-10-30
• Device Publish Date: 2019-10-22

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