FDA.reportPublic FDA data

Yoni.Fit Bladder Support

Primary DI
00850019563139
Brand
Yoni.Fit Bladder Support
Company
Watkins-Conti Products, Inc.
Model
PT-1003
Device description
Yoni.Fit Bladder Support Size 2
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHWPessary, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
10850019563136PackageGS18In Commercial Distribution
00850019563139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001956313610850019563136
00850019563139008500195631398500195631390850019563139

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 Diameter38Millimeter

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
Premarket exempt
false
HCT/P
false
Kit
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019563122Yoni.Fit Bladder SupportPT-10022024-07-31
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
00850019563191Yoni.Fit Bladder SupportPT-A-0011 2024-07-31
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09903124199456CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2026-02-22
00999999999993CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2026-02-22
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
00810142350334Bioteque America, Inc.Bioteque America, Inc.HHW2025-06-02
00810142350587Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350594Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350600Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350617Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350624Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350631Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350648Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350655Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350662Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350679Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350686Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350693Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350709Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350716Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350723Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350730Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350754Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350761Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350778Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350785Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350792Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29