Elvie

GUDID 05060442520004

Kegel exercise tracker

CHIARO TECHNOLOGY LIMITED

Pelvic floor muscle exerciser

• Primary Device ID: 05060442520004
• NIH Device Record Key: 4fbacc49-bd9a-4426-aced-c7ab29434277
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elvie
• Version Model Number: EL01 - Celeste
• Company DUNS: 219386662
• Company Name: CHIARO TECHNOLOGY LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	05060442520004 [Primary]

FDA Product Code

• KXQ: Vibrator For Therapeutic Use, Genital

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: 2018-06-04
• Device Publish Date: 2018-05-03

Devices Manufactured by CHIARO TECHNOLOGY LIMITED

• 05060442521988 - Elvie Stride 2: 2024-10-17 Powered breast pump
• 05060442521995 - Elvie Stride 2 with Neck Strap: 2024-10-17 Powered Breast Pump
• 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