AccessGUDID - DEVICE: LIBERTY (H671PFS2000)

GUDID

Device Identifier (DI) Information

Brand Name: LIBERTY
Version or Model: Stimulator
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PFS-200
Company Name: UTAH MEDICAL PRODUCTS, INC.

Primary DI Number: H671PFS2000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094651270 *Terms of Use

Device Description: Pelvic Floor Execiser System, Stimulator Unit, For use with Liberty execiser probes only, Includes Carrying Case, Batteries, and Instructional DVD

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:	No
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?
66773	Perineal orifice incontinence-control electrical stimulation system generator	A noninvasive electrically-powered component of a perineal orifice incontinence-control electrical stimulation system designed to generate electrical signals (pulses) for treatment of urinary and/or faecal incontinence by a healthcare professional. It is designed to be connected to an intravaginal/intra-anal probe (not included) for delivery of the electrical stimuli which are intended to induce Kegel-like contractions in the muscles of the pelvic floor.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960496	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
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d303ed12-a9c1-47bf-ab50-21b5fdad8807
Public Version Date: August 27, 2024
Public Version Number: 4
DI Record Publish Date: September 23, 2016