Intimate Rose

GUDID 00850005838135

Intimate Rose Kegel Exercise System for pelvic floor weakness. Includes 6 silicone weights and instructions.

PLUS EV HOLDINGS INC.

Pelvic floor muscle exerciser

• Primary Device ID: 00850005838135
• NIH Device Record Key: d824deac-90d1-4e94-a159-69b4ca2ee78f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intimate Rose
• Version Model Number: IR-002
• Company DUNS: 054962595
• Company Name: PLUS EV HOLDINGS 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 888-534-7673
• Email: support@intimaterose.com
• Phone: 888-534-7673
• Email: support@intimaterose.com
• Phone: 888-534-7673
• Email: support@intimaterose.com
• Phone: 888-534-7673
• Email: support@intimaterose.com
• Phone: 888-534-7673
• Email: support@intimaterose.com
• Phone: 888-534-7673
• Email: support@intimaterose.com
• Phone: 888-534-7673
• Email: support@intimaterose.com
• Phone: 888-534-7673
• Email: support@intimaterose.com
• Phone: 888-534-7673
• Email: support@intimaterose.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005838135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193364

FDA Product Code

• HIR: Perineometer

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: 2020-11-06
• Device Publish Date: 2020-10-29