The DivaCup DV002

GUDID 10857538000043

Menstrual Cup, 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, non-latex, reusable

• Primary Device ID: 10857538000043
• NIH Device Record Key: e8e0512f-01f8-4cc6-8d7b-1397e95ca5ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The DivaCup
• Version Model Number: Model 2
• Catalog Number: DV002
• Company DUNS: 207651758
• Company Name: Diva International Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: true

Customer Support Contacts

• Phone: 18664443482
• Email: ISORegulatory@divacup.com
• Phone: 18664443482
• Email: ISORegulatory@divacup.com
• Phone: 18664443482
• Email: ISORegulatory@divacup.com
• Phone: 18664443482
• Email: ISORegulatory@divacup.com
• Phone: 18664443482
• Email: ISORegulatory@divacup.com
• Phone: 18664443482
• Email: ISORegulatory@divacup.com
• Phone: 18664443482
• Email: ISORegulatory@divacup.com
• Phone: 18664443482
• Email: ISORegulatory@divacup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857538000022 [Primary]
GS1	10857538000043 [Package]; Contains: 00857538000022; Package: Master Case box [60 Units]; In Commercial Distribution
GS1	10857538000081 [Package]; Contains: 00857538000022; Package: Box inner case [6 Units]; In Commercial Distribution
GS1	10857538000272 [Package]; Contains: 00857538000022; Package: Box inner case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021356

FDA Product Code

• HHE: Cup, Menstrual

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-09
• Device Publish Date: 2017-07-27

On-Brand Devices [The DivaCup]

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• 00857538000237: Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use
• 00857538000169: Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use
• 00857538000152: Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use
• 00857538000145: Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use
• 00857538000138: Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use
• 10857538000043: Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use
• 10857538000258: Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use
• 00050428645888: Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use
• 00050428645598: Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the use