Omnistim FX2 Continence Plus Portable

Basic Information

• Brand Name: Omnistim FX2 Continence Plus Portable
• Primary DI: 00858703006122
• Version / Model: 300100A
• Company Name: ACCELERATED CARE PLUS CORP
• Labeler DUNS: 828331616
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-16
• Public Version: 6
• Public Version Date: 2023-08-22
• Public Version Status: Update
• Public Device Record Key: b068d695-1ee5-4356-9577-4cb7fd117659
• Distribution End Date: 2023-08-21

Device Description

Non-implantable electrical stimulator for incontinence

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	876.5320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858703006122	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]