Ameda

GUDID 39551028430000

TPH TECHNOLOGY MALAYSIA SDN. BHD.

Breast pump, electric

• Primary Device ID: 39551028430000
• NIH Device Record Key: c1ca15bb-b4df-4ae4-b2d3-b5ae2635f997
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ameda
• Version Model Number: W8S
• Company DUNS: 965318820
• Company Name: TPH TECHNOLOGY MALAYSIA SDN. BHD.
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	19551028430006 [Primary]
GS1	39551028430000 [Package]; Contains: 19551028430006; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250463

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: 2026-03-11
• Device Publish Date: 2026-03-03