Swing Maxi

GUDID 07612367078160

Double electric, single user breast pump intended to express & collect breast milk

MEDELA, INC.

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• Primary Device ID: 07612367078160
• NIH Device Record Key: 0c6cc2e1-d609-44f7-8a5a-086150307c83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swing Maxi
• Version Model Number: 101043638
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020451436388 [Primary]
GS1	07612367078160 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210759

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: 2022-03-09
• Device Publish Date: 2022-03-01

On-Brand Devices [Swing Maxi]

• 00020451436142: Double electric, single user breast pump intended to express & collect breast milk
• 07612367078160: Double electric, single user breast pump intended to express & collect breast milk