OmniVersa High Conductivity Electrodes

Basic Information

• Brand Name: OmniVersa High Conductivity Electrodes
• Primary DI: 00858703006306
• Version / Model: 26135
• Company Name: ACCELERATED CARE PLUS CORP
• Labeler DUNS: 828331616
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-22
• Public Version: 2
• Public Version Date: 2022-08-29
• Public Version Status: Update
• Public Device Record Key: af3d1be5-3083-4e98-9745-1e173b46ad48

Device Description

OmniVersa High Conductivity Electrodes, 2.75 x 5

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35995	Transcutaneous electrical stimulation electrode, single-use	An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10858703006303	GS1	Inner Pack	4	In Commercial Distribution
Primary	00858703006306	GS1
Package	20858703006300	GS1	Case	10	In Commercial Distribution
Package	30858703006307	GS1	Display Shipper	10	In Commercial Distribution

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 40 – 80.6 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 35 – 50 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 35 – 50 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 40 – 80.6 Degrees Fahrenheit