Abana Essentials LLC

GUDID 36973493598031

Shenzhen TPH Technology Co., Ltd

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• Primary Device ID: 36973493598031
• NIH Device Record Key: d96c2bb0-dee2-4eac-b7a4-b9f36798ac70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abana Essentials LLC
• Version Model Number: S12-D
• 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	06973493598337 [Primary]
GS1	36973493598031 [Package]; Contains: 06973493598337; Package: [24 Units]; In Commercial Distribution

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: 2023-12-14
• Device Publish Date: 2023-12-06

On-Brand Devices [Abana Essentials LLC]

• 06973493595794: S12
• 36973493598031: S12-D