Paruu

GUDID 06970303251529

The Electric Breast Pump are powered breast pumps intended to express and collect milk from a lactating woman’s breast. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The Electric Breast Pump is provided non-sterile and should be cleaned and disinfected according to the instructions for use prior to first use. The user employs buttons on the pump unit to select the pumping mode and vacuum leve

Shantou Huihengqi Electronic Technology Co., Ltd

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• Primary Device ID: 06970303251529
• NIH Device Record Key: 573e7553-7ddc-433e-9141-be35ceb564f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paruu
• Version Model Number: P10(pink)
• Company DUNS: 542341613
• Company Name: Shantou Huihengqi Electronic 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970303251529 [Primary]
GS1	16970303251526 [Package]; Package: [2 Units]; Discontinued: 2024-02-01; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211024

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: 2024-02-09
• Device Publish Date: 2024-02-01

On-Brand Devices [Paruu]

• 06970303251444: The Electric Breast Pump are powered breast pumps intended to express and collect milk from a la
• 16970303251434: The Electric Breast Pump are powered breast pumps intended to express and collect milk from a la
• 06970303251529: The Electric Breast Pump are powered breast pumps intended to express and collect milk from a la