FDA.reportPublic FDA data

Yoni.Fit Bladder Support

Primary DI
00850019563214
Brand
Yoni.Fit Bladder Support
Company
Watkins-Conti Products, Inc.
Model
PT-A-0012
Catalog number
Yoni Fit Kit Two Teal
Device description
Yoni.Fit Bladder Support Kit Two - Teal: Includes Sizes 3 and 3.5, Storage Container, Cleaning Brush, and Instructions for Use
Published
2024-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHECup, Menstrual
HHWPessary, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHECup, MenstrualObstetrics/Gynecology2
HHWPessary, VaginalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232525000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850019563211PackageGS16In Commercial Distribution
00850019563214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001956321110850019563211
00850019563214008500195632148500195632140850019563214

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Outer Diameter42Millimeter
Outer Diameter45Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-844-966-4348Sales@yonifit.com

Regulatory Flags#

DUNS number
053049687
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019563122Yoni.Fit Bladder SupportPT-1002Yoni Fit Size 1 Replacement2024-07-31
00850019563139Yoni.Fit Bladder SupportPT-1003Yoni Fit Size 2 Replacement2024-07-31
00850019563146Yoni.Fit Bladder SupportPT-1004Yoni Fit Size 3 Replacement2024-07-31
00850019563153Yoni.Fit Bladder SupportPT-1005Yoni Fit Size 4 Replacement2024-07-31
00850019563160Yoni.Fit Bladder SupportPT-1006Yoni Fit Size 5 Replacement2024-07-31
00850019563177Yoni.Fit Bladder SupportPT-1007Yoni Fit Size 3.5 Replacement2024-07-31
00850019563191Yoni.Fit Bladder SupportPT-A-0011 Yoni Fit Kit One Purple2024-07-31
00850019563252Yoni.Fit Bladder SupportPT-A-0013Yoni Fit Kit Three Pink2024-07-31
00850019563269Yoni.Fit Bladder SupportPT-A-0015 Yoni Fit Kit Four2024-07-31
00850019563276Yoni.Fit Bladder SupportPT-A-0016 Yoni Fit Kit Five2024-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09903124199524CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2026-02-22
G391ANGCRLG2Angelcup - CrystalGrupo IX Kaan, S.A. de C.V.HHE2023-01-10
G391ANGCRSM2Angelcup - CrystalGrupo IX Kaan, S.A. de C.V.HHE2023-01-10
G391ANGLILLG2Angelcup - LilacGrupo IX Kaan, S.A. de C.V.HHE2023-01-10
G391ANGLILSM2Angelcup - LilacGrupo IX Kaan, S.A. de C.V.HHE2023-01-10
G391ANGPKLG2Angelcup - PinkGrupo IX Kaan, S.A. de C.V.HHE2023-01-10
G391ANGPKSM2Angelcup - PinkGrupo IX Kaan, S.A. de C.V.HHE2023-01-10
G357DA0Kind CupWevotopia LLCHHE2022-11-28
09421906547023LORcupX-HALTATION LIMITEDHHE2021-01-20
09421906547030LORcupX-HALTATION LIMITEDHHE2021-01-20
08055349618005Mamicup®MADALU' SRLHHE2020-04-15
08055349618012Mamicup®MADALU' SRLHHE2020-04-15
08055349618029Mamicup®MADALU' SRLHHE2020-04-15
08055349618036Mamicup®MADALU' SRLHHE2020-04-15
08055349618043Mamicup®MADALU' SRLHHE2020-04-15
08055349618050Mamicup®MADALU' SRLHHE2020-04-15
08055349618067Mamicup®MADALU' SRLHHE2020-04-15
08055349618074Mamicup®MADALU' SRLHHE2020-04-15
09421904034242OiORGANIC INITIATIVE CORPORATIONHHE2020-04-02
09421904034259OiORGANIC INITIATIVE CORPORATIONHHE2020-04-02
09421904034266OiORGANIC INITIATIVE CORPORATIONHHE2020-04-02
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