Ameda 17451

GUDID 00810725025437

AMEDA, INC.

Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile Breast pump support kit, single-use, sterile

• Primary Device ID: 00810725025437
• NIH Device Record Key: e21083c2-77a8-464c-a120-7c4227538ff5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ameda
• Version Model Number: HygieniKit Plus
• Catalog Number: 17451
• Company DUNS: 078719435
• Company Name: AMEDA, 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: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com
• Phone: 866-992-6332
• Email: parentcare@ameda.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810725022405 [Primary]
GS1	00810725025437 [Package]; Contains: 00810725022405; Package: carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011519

FDA Product Code

• OHH: Breast Pump Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-05
• Device Publish Date: 2021-04-27

On-Brand Devices [Ameda]

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• 00810725025086: Double Electric Breast Pump
• 00810725025079: Double electric breast pump with large tote
• 00810725025062: Double Electric Breast Pump
• 00810725022702: HygieniKit Plus
• 00810725025437: HygieniKit Plus
• 00810725025772: Double Electric Breast Pump with Tote Bag, Cooler Bag and Manual Pump
• 00810725025598: Double electric breast pump with deluxe edition accessories and spare parts
• 00810725025581: Double electric breast pump with tote bag
• 00810725025574: Double electric breast pump
• 10810725025823: Dual milk collection system