Healcan

GUDID 06973493590850

Shenzhen TPH Technology Co., Ltd

Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric Breast pump, electric

• Primary Device ID: 06973493590850
• NIH Device Record Key: e1f12b36-4d76-4d4b-9749-bd5b72cad3b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healcan
• 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	06973493590850 [Primary]
GS1	06973493594858 [Package]; Package: carton [32 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: 2022-07-25
• Device Publish Date: 2022-07-15

Devices Manufactured by Shenzhen TPH Technology Co., Ltd

• 36973493598031 - Abana Essentials LLC: 2023-12-14
• 16973493593766 - lansinoh: 2023-11-27
• 06973493595794 - Abana Essentials LLC: 2023-08-22
• 06973493599198 - Goldeep: 2022-10-03
• 06973493594179 - Goldeep: 2022-10-03
• 06973493590317 - Goldeep: 2022-09-12
• 06973493597316 - Goldeep: 2022-08-29
• 06973493599860 - Goldeep: 2022-08-16