Solo™ Hands-free

GUDID 07612367089470

Medela LLC

Breast pump, electric

• Primary Device ID: 07612367089470
• NIH Device Record Key: dd9ad625-ebea-410f-8953-10eb20ab532b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solo™ Hands-free
• Version Model Number: 101047309
• Company DUNS: 052002029
• Company Name: Medela LLC
• 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: true

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612367089463 [Primary]
GS1	07612367089470 [Package]; Contains: 07612367089463; Package: [6 Units]; In Commercial Distribution
GS1	07612367089685 [Direct Marking]

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: 2025-05-19
• Device Publish Date: 2025-05-09

Devices Manufactured by Medela LLC

• 07612367089470 - Solo™ Hands-free: 2025-05-19
• 07612367089470 - Solo™ Hands-free: 2025-05-19
• 10020451456703 - Duo Hands-free: 2025-04-08
• 00020451000411 - Symphony Single Kit-Sterile: 2024-09-30 Breastpump Kit.
• 20020451100047 - Enteral Feeding: 2024-09-30 Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.30 mL, FLL/Adapter
• 20020451100054 - Enteral Feeding: 2024-09-30 Bifurcated Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.70 mL, FLL/Adapter
• 20020451100061 - Enteral Feeding: 2024-09-30 Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.20 mL, FLL/MLL
• 20020451100078 - Enteral Feeding: 2024-09-30 Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.30 mL, TwistLok/Adapter
• 20020451100085 - Enteral Feeding: 2024-09-30 Enteral Extension Set, 60", Minibore, Approx. Priming Vol. 2.00 mL, TwistLok/Adapter