Diva Biome Balancer Applicator

GUDID 00841445001388

Vaginal suppository applicator

Diva International Inc

Vaginal applicator, reusable

• Primary Device ID: 00841445001388
• NIH Device Record Key: 28142607-4714-40d3-a048-189d144057c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diva Biome Balancer Applicator
• Version Model Number: 1
• Company DUNS: 207651758
• Company Name: Diva International Inc
• 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: false
• Manufacturing Date: false
• 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	00841445001388 [Primary]

FDA Product Code

• HGD: Applicator, Vaginal

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: 2026-02-16
• Device Publish Date: 2026-02-06

Devices Manufactured by Diva International Inc

• 00841445001388 - Diva Biome Balancer Applicator: 2026-02-16Vaginal suppository applicator
• 00841445001388 - Diva Biome Balancer Applicator: 2026-02-16 Vaginal suppository applicator
• 00841445001326 - DivaCup Impact: 2025-09-09 Medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and
• 00841445001333 - DivaCup Impact: 2025-09-09 Medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and
• 00841445001340 - DivaCup Impact: 2025-09-09 Medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and
• 00841445001111 - Diva Lubricator: 2025-04-09 This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the
• 00841445001104 - Diva Lubricator: 2025-03-31 This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the
• 00050428645598 - The DivaCup: 2024-09-27 Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place
• 00050428645888 - The DivaCup: 2024-09-27 Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place