AccessGUDID - DEVICE: Lifecare (04719871183137)

GUDID

Device Identifier (DI) Information

Brand Name: Lifecare
Version or Model: PR-20H
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

Primary DI Number: 04719871183137
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657383535 *Terms of Use

Device Description: Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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":	Yes
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?
36050	Perineal orifice incontinence-control electrical stimulation system probe, reusable	An invasive electrical conductor which is a component of a perineal orifice incontinence-control electrical stimulator intended for the treatment of urinary and/or faecal incontinence through the intravaginal/intra-anal application of electrical stimuli to the muscles of the pelvic floor. It connects to an external pulse generator (not included) and is in the form of a cylinder-like probe with surface electrodes for insertion into the vagina and/or anus whereby therapy involves induction of Kegel-like contractions. It is intended for use in both the home (self-treatment) and healthcare facility. This is a reusable device.	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 [?]
K122194	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0abbf9cf-a93d-47b5-bc01-802625416cf6
Public Version Date: December 11, 2023
Public Version Number: 5
DI Record Publish Date: December 02, 2016