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

• 05060442520561 - Elvie Pump Single AMZA: 2025-02-19 Elvie Pump - Single Electric Breast Pump - AMZA - Baked Breast pump, powered
• 05060442522077 - Elvie Stride 2: 2025-01-23 Powered breast pump - Single
• 05060442522084 - Elvie Stride 2 Breast Shield: 2025-01-23 Elvie Stride 2 Breast Shield 2 x 28mm Breast Shield
• 05060442522107 - Elvie Stride 2 Connect Kit (Single): 2025-01-23 Elvie Stride 2 Connect Kit (Single). 1xCap Assembly, 1xLong PVC Tube with Puck Connector
• 05060442522114 - Elvie Stride 2 Connect Kit (Double): 2025-01-23 Elvie Stride 2 Connect Kit (Double) 2 Cap Assembly, 2xSilicone Tubes, 1xSplitter, 1xTube Splitter Bung, 1xPVC Tube with Puck Con
• 05060442522121 - Elvie Stride 2 Cups: 2025-01-23 Elvie Stride 2 Cups 2 x Cups
• 05060442522138 - Elvie Stride 2 Diaphragm: 2025-01-23 Elvie Stride 2 Diaphragm 2 x Diaphragm
• 05060442522152 - Elvie Stride 2 Valves: 2025-01-23 Elvie Stride 2 Valves 3 x Valves