Elvie Stride

GUDID 05060442520615

CHIARO TECHNOLOGY LIMITED

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• Primary Device ID: 05060442520615
• NIH Device Record Key: 3f0ca021-6a86-47ed-bf0e-52b72e0566be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elvie Stride
• Version Model Number: EB01
• Company DUNS: 219386662
• Company Name: CHIARO TECHNOLOGY LIMITED
• Device Count: 1
• DM Exempt: true
• 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	05060442520615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210936

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: 2021-09-22
• Device Publish Date: 2021-09-14

Devices Manufactured by CHIARO TECHNOLOGY LIMITED

• 05060442521759 - Elvie Nipple Cushion: 2023-06-02 Pair of Nipple Cushions, 15 mm
• 05060442521766 - Elvie Nipple Cushion: 2023-06-02 Pair of Nipple Cushions, 17 mm
• 05060442521773 - Elvie Nipple Cushions: 2023-06-02 Pair of Nipple Cushions, 19 mm
• 05060442521797 - Elvie Pump Double: 2023-06-02 Breast pump, powered
• 05060442521544 - Elvie Pump Kit: 2023-03-15 Breast Pump Kit
• 05060442520622 - Elvie Stride Plus: 2022-03-22 Breast Pump, Powered
• 05060442520615 - Elvie Stride: 2021-09-22
• 05060442520615 - Elvie Stride: 2021-09-22
• 05060442520547 - Elvie Curve: 2021-08-31 Elvie Curve, Manual Breast Pump