Yoni.Fit Bladder Support

Basic Information

• Brand Name: Yoni.Fit Bladder Support
• Primary DI: 00850019563146
• Version / Model: PT-1004
• Catalog Number: Yoni Fit Size 3 Replacement
• Company Name: Watkins-Conti Products, Inc.
• Labeler DUNS: 053049687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-31
• Public Version: 4
• Public Version Date: 2026-04-07
• Public Version Status: Update
• Public Device Record Key: 38288f61-a9c7-495f-831c-6ee0aae1f1df

Device Description

Yoni.Fit Bladder Support Size 3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
HHE	Cup, Menstrual	Obstetrics/Gynecology	884.5400	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
61853	Urinary-incontinence vaginal insert, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850019563146	GS1
Package	10850019563143	GS1		6	Not in Commercial Distribution	2025-02-26
Package	20850019563140	GS1	Case	8	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K232525	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	42	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius