AccessGUDID - DEVICE: PeriCoach® (09338067000581)

GUDID

Device Identifier (DI) Information

Brand Name: PeriCoach®
Version or Model: PC0100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STRATOS MEDTECH PTY LTD

Primary DI Number: 09338067000581
Issuing Agency: GS1
Commercial Distribution End Date: April 11, 2032
Device Count: 1
Labeler D-U-N-S® Number*: 751072256 *Terms of Use

Device Description: The PeriCoach is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology. The PeriCoach® device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of contraction of the user’s pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device.

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):	No
Over the Counter (OTC):	Yes
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?
32686	Perineometer	A device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The device measures the strength of the perineal muscles by offering resistance to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, urinary incontinence or sexual dysfunction.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIR	Perineometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160758	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 Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between .7 and 1.06 KiloPascal
Handling Environment Atmospheric Pressure: between .7 and 1.06 KiloPascal
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Temperature: between -25 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eabe6dc9-7c83-4f50-b398-7e4df8b8005b
Public Version Date: July 12, 2024
Public Version Number: 3
DI Record Publish Date: April 10, 2017