AccessGUDID - DEVICE: Yoni.Fit Bladder Support (00850019563191)

GUDID

Device Identifier (DI) Information

Brand Name: Yoni.Fit Bladder Support
Version or Model: PT-A-0011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Yoni Fit Kit One Purple
Company Name: Watkins-Conti Products, Inc.

Primary DI Number: 00850019563191
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053049687 *Terms of Use

Device Description: Yoni.Fit Bladder Support Kit One - Purple: Includes Sizes 1 and 2, Storage Container, Cleaning Brush, and Instructions for Use

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHW	Pessary, Vaginal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232525	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 34 Millimeter
Outer Diameter: 38 Millimeter

Device Record Status

Public Device Record Key: 394182ad-3a44-419a-93ed-5ede3db358d7
Public Version Date: March 05, 2025
Public Version Number: 3
DI Record Publish Date: July 31, 2024