Sword Bloom

GUDID 05065013876030

SWORD HEALTH, S.A.

Pelvic floor muscle exerciser

• Primary Device ID: 05065013876030
• NIH Device Record Key: 3a4abcad-8361-4113-ae71-293ab1e0d045
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sword Bloom
• Version Model Number: 7
• Company DUNS: 338007105
• Company Name: SWORD HEALTH, S.A.
• 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: 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	05065013876023 [Primary]
GS1	05065013876030 [Package]; Contains: 05065013876023; Package: [1 Units]; In Commercial Distribution

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: 2024-08-02
• Device Publish Date: 2024-07-25

Devices Manufactured by SWORD HEALTH, S.A.

• 05065013876030 - Sword Bloom: 2024-08-02
• 05065013876030 - Sword Bloom: 2024-08-02
• 05065013876009 - Digital Therapist: 2023-09-15
• 05600775530563 - Bloom: 2023-09-15
• 05600775530136 - Digital Therapist: 2021-10-25
• 05600775530143 - Digital Therapist: 2021-10-25
• 05600775530259 - Digital Therapist: 2021-10-25
• 05600775530266 - Digital Therapist: 2021-10-25
• 05600775530273 - Digital Therapist: 2021-10-25