Ameda, Inc 10004

GUDID 10810725023089

Tubing Adapter

AMEDA, INC.

Breast pump support kit, single-use, sterile

• Primary Device ID: 10810725023089
• NIH Device Record Key: d9340328-dfe4-4219-8da0-7309ea9ef3a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ameda, Inc
• Version Model Number: 10004
• Catalog Number: 10004
• Company DUNS: 078719435
• Company Name: AMEDA, INC.
• Device Count: 2
• 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: false
• 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: (866) 992-6332
• Email: parentcare@ameda.com
• Phone: (866) 992-6332
• Email: parentcare@ameda.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810725023082 [Primary]
GS1	00810725023198 [Unit of Use]
GS1	10810725023089 [Package]; Contains: 00810725023082; Package: Outer Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011519

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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