Revive

Basic Information

• Brand Name: Revive
• Primary DI: 00854389008009
• Version / Model: 0025
• Catalog Number: 0025
• Company Name: RINOVUM SUBSIDIARY 2, LLC
• Labeler DUNS: 081362926
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-04
• Public Version: 1
• Public Version Date: 2019-04-12
• Public Version Status: New
• Public Device Record Key: 3e1a4340-7ee8-4073-9dc2-288285337dc5

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHW	Pessary, Vaginal	Obstetrics/Gynecology	884.3575	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59082	Urinary-incontinence vaginal insert, reusable	A non-sterile, device intended to be inserted into the vagina in order to relieve mixed or stress urinary incontinence in an adult female by providing urethral support when pressure is transferred from the abdomen to the pelvic floor area (e.g. upon coughing, laughing, sneezing, exertion). It is a non-absorbent device with a removal cord; an application kit (tube and push rod) is typically included. This is a reusable device - after appropriate cleaning - intended for single-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20854389008027	GS1	Case	6	In Commercial Distribution
Package	10854389008020	GS1	Case	16	In Commercial Distribution
Package	00854389008023	GS1	Inner	2	In Commercial Distribution
Primary	00854389008009	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K183468	000