Philips Avent Double electric breast pump Advanced SCF394/61

GUDID 00075020091512

Powered breast pump consisting of a motor unit with a press-button user interface, and 2 expression kits (Cushion-type) with 2 milk collection containers. With a rechargeable battery.

Philips Consumer Lifestyle B.V.

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• Primary Device ID: 00075020091512
• NIH Device Record Key: f04c84f4-ae01-453d-be4e-22dfa14ba30a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips Avent Double electric breast pump Advanced
• Version Model Number: SCF394/61
• Catalog Number: SCF394/61
• Company DUNS: 489122720
• Company Name: Philips Consumer Lifestyle B.V.
• 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: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com
• Phone: +31618191888
• Email: aurore.millet@philips.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00075020091512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203383

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: 2021-01-14
• Device Publish Date: 2021-01-06

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• 00075020104045: Powered breast pump consisting of a motor unit with a press-button user interface, INCLUDES; X2