Sonata Breastpump

GUDID 20020451582003

Double Electric Breast Pump

Medela LLC

Breast pump, electric

• Primary Device ID: 20020451582003
• NIH Device Record Key: 66cb9463-d897-4d76-bbba-04985cdd449e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonata Breastpump
• Version Model Number: Sonata Deluxe
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020451582009 [Primary]
GS1	10020451582006 [Package]; Contains: 00020451582009; Package: Carton [1 Units]; In Commercial Distribution
GS1	20020451582003 [Package]; Contains: 00020451582009; Package: Carton [2 Units]; In Commercial Distribution
GS1	30020451581058 [Package]; Contains: 00020451582009; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161725

FDA Product Code

• HGX: Pump, Breast, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-09-30
• Device Publish Date: 2016-11-16

Devices Manufactured by Medela LLC

• 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
• 20020451100092 - Enteral Feeding: 2024-09-30 Bifurcated Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.70 mL, TwistLok/Adapter
• 20020451100108 - Enteral Feeding: 2024-09-30 Bifurcated Enteral Extension Set, 60", Minibore, Approx. Priming Vol. 2.20 mL, TwistLok/Adapter