FDA.report

Yoni.Fit Bladder Support

Primary DI
00850019563191
Brand
Yoni.Fit Bladder Support
Company
Watkins-Conti Products, Inc.
Model
PT-A-0011
Device description
Yoni.Fit Bladder Support Kit One - Purple: Includes Sizes 1 and 2, Storage Container, Cleaning Brush, and Instructions for Use
Published
2024-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HHWPessary, Vaginal

Product Code Classifications

CodeDeviceSpecialtyClass
HHWPessary, VaginalObstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K232525000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K232525000Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.2024-05-17HHW

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10850019563198PackageGS16In Commercial Distribution
00850019563191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001956319810850019563198
00850019563191008500195631918500195631910850019563191

GMDN Terms

TermDefinition
Urinary-incontinence vaginal insert, reusableA 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.

Device Sizes

TypeValueUnit
Outer Diameter34Millimeter
Outer Diameter38Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
1-844-966-4348Sales@yonifit.com

Regulatory Flags

DUNS number
053049687
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850019563122Yoni.Fit Bladder SupportPT-10022024-07-31
00850019563139Yoni.Fit Bladder SupportPT-10032024-07-31
00850019563146Yoni.Fit Bladder SupportPT-10042024-07-31
00850019563153Yoni.Fit Bladder SupportPT-10052024-07-31
00850019563160Yoni.Fit Bladder SupportPT-10062024-07-31
00850019563177Yoni.Fit Bladder SupportPT-10072024-07-31
00850019563214Yoni.Fit Bladder SupportPT-A-00122024-07-31
00850019563252Yoni.Fit Bladder SupportPT-A-00132024-07-31
00850019563269Yoni.Fit Bladder SupportPT-A-0015 2024-07-31
00850019563276Yoni.Fit Bladder SupportPT-A-0016 2024-07-31

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
09903124199456CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2026-02-22
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09903124199692CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2026-02-22
09903124199906CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2026-02-22
00990312419945CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2025-08-22
00990312419952CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2025-08-22
00990312419969CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2025-08-22
00990312419990CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2025-08-22
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