DivaCup Impact DV000

GUDID 00841445001326

Medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons. It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.

Diva International Inc

Menstrual cup/disc, non-latex, reusable

• Primary Device ID: 00841445001326
• NIH Device Record Key: cb6ecbcf-1d49-4003-8186-46232d84c24b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DivaCup Impact
• Version Model Number: Model 0
• Catalog Number: DV000
• 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: true
• Serial Number: false
• 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	00841445001326 [Primary]

FDA Product Code

• HHE: Cup, Menstrual

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: 2025-09-09
• Device Publish Date: 2025-09-01

On-Brand Devices [DivaCup Impact]

• 00841445001340: Medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagi
• 00841445001333: Medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagi
• 00841445001326: Medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagi