Sonata Breastpump 101037319

GUDID 10020451367504

Double Electric Breast Pump

MEDELA, INC.

Breast pump, electric

• Primary Device ID: 10020451367504
• NIH Device Record Key: 5ede8cc7-5dc1-4f4a-b0bb-8d4dd3d5f517
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonata Breastpump
• Version Model Number: Sonata Deluxe
• Catalog Number: 101037319
• Company DUNS: 052002029
• Company Name: MEDELA, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020451367507 [Primary]
GS1	10020451367504 [Package]; Contains: 00020451367507; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-01
• Device Publish Date: 2019-06-21

Devices Manufactured by MEDELA, INC.

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• 20020451100894 - Enteral Feeding: 2023-11-29 INTOPO Cap
• 20020451101181 - Enteral Feeding: 2023-11-29 Male TwistLok Non-Vented Cap, 10 units/package
• 10020451101467 - Enteral Feeding: 2023-11-29 Med Cap, Non-Sterile, ENFit, Low Dose