Revive 0025

GUDID 20854389008027

The Revive reusable bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.

RINOVUM SUBSIDIARY 2, LLC

Urinary-incontinence vaginal insert, reusable

• Primary Device ID: 20854389008027
• NIH Device Record Key: 3e1a4340-7ee8-4073-9dc2-288285337dc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revive
• Version Model Number: 0025
• Catalog Number: 0025
• Company DUNS: 081362926
• Company Name: RINOVUM SUBSIDIARY 2, LLC
• 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: 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: true

Customer Support Contacts

• Phone: 412-200-2803
• Email: info@userevive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854389008009 [Primary]
GS1	00854389008023 [Package]; Contains: 00854389008009; Package: Inner [2 Units]; In Commercial Distribution
GS1	10854389008020 [Package]; Contains: 00854389008023; Package: Case [16 Units]; In Commercial Distribution
GS1	20854389008027 [Package]; Contains: 10854389008020; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183468

FDA Product Code

• HHW: Pessary, 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: 2019-04-12
• Device Publish Date: 2019-04-04