Freestyle Flex

GUDID 07612367071918

Breast Pump

Medela AG

Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric 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

Devices Manufactured by Medela AG

• 07612367025133 - Docking Station Adapter for canister 2 L: 2024-06-11 Adapter to docking station for Thopaz canister 2L
• 07612367038713 - Standard rail universal holder: 2024-06-11 Universal clamp with standard rail
• 07612367000109 - Silicone tubing ID 6.5mm, 180cm, 1 coupling piece: 2024-06-10 Silicone tubing ID 6.5mm, 180cm, 1 coupling piece
• 07612367003551 - Quiver 280mm: 2024-06-10 Quiver 280mm
• 07612367003568 - Quiver 480mm: 2024-06-10 Quiver 480mm
• 07612367003575 - Change over valve: 2024-06-10 Change over valve
• 07612367003698 - Overflow protection device: 2024-06-10 Overflow protection device
• 07612367003735 - Reusable serial connector: 2024-06-10 Reusable serial connector