Home GUDID 00850019563191 Yoni.Fit Bladder Support
Primary DI 00850019563191
Brand Yoni.Fit Bladder Support
Company Watkins-Conti Products, Inc.
Model PT-A-0011
Catalog number Yoni Fit Kit One Purple
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 Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HHE Cup, Menstrual HHW Pessary, Vaginal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HHE Cup, Menstrual Obstetrics/Gynecology 2 HHW Pessary, Vaginal Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850019563198 Package GS1 6 In Commercial Distribution 00850019563191 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10850019563198 10850019563198 00850019563191 00850019563191 850019563191 0850019563191
GMDN Terms# Term, Definition table Term Definition 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.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 34 Millimeter Outer Diameter 38 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 20 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 68 Degrees Fahrenheit 77 Degrees Fahrenheit
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 DI Brand Model Catalog Published 00850019563122 Yoni.Fit Bladder Support PT-1002 Yoni Fit Size 1 Replacement 2024-07-31 00850019563139 Yoni.Fit Bladder Support PT-1003 Yoni Fit Size 2 Replacement 2024-07-31 00850019563146 Yoni.Fit Bladder Support PT-1004 Yoni Fit Size 3 Replacement 2024-07-31 00850019563153 Yoni.Fit Bladder Support PT-1005 Yoni Fit Size 4 Replacement 2024-07-31 00850019563160 Yoni.Fit Bladder Support PT-1006 Yoni Fit Size 5 Replacement 2024-07-31 00850019563177 Yoni.Fit Bladder Support PT-1007 Yoni Fit Size 3.5 Replacement 2024-07-31 00850019563214 Yoni.Fit Bladder Support PT-A-0012 Yoni Fit Kit Two Teal 2024-07-31 00850019563252 Yoni.Fit Bladder Support PT-A-0013 Yoni Fit Kit Three Pink 2024-07-31 00850019563269 Yoni.Fit Bladder Support PT-A-0015 Yoni Fit Kit Four 2024-07-31 00850019563276 Yoni.Fit Bladder Support PT-A-0016 Yoni Fit Kit Five 2024-07-31
Other Devices Sharing Product Codes# 
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