Abana Essentials LLC

GUDID 06973493595794

Shenzhen TPH Technology Co., Ltd

Breast pump, electric

• Primary Device ID: 06973493595794
• NIH Device Record Key: 0ff4efab-c32b-4e13-8cff-4b42e31f2c5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abana Essentials LLC
• Version Model Number: S12
• Company DUNS: 403304567
• Company Name: Shenzhen TPH Technology Co., Ltd
• 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: false
• 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	06973493595794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212180

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: 2023-08-22
• Device Publish Date: 2023-08-14

On-Brand Devices [Abana Essentials LLC]

• 06973493595794: S12
• 36973493598031: S12-D