AccessGUDID - DEVICE: OmniVersa High Conductivity Electrodes (00858703006238)

GUDID

Device Identifier (DI) Information

Brand Name: OmniVersa High Conductivity Electrodes
Version or Model: 26122
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 26122
Company Name: ACCELERATED CARE PLUS CORP

Primary DI Number: 00858703006238
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828331616 *Terms of Use

Device Description: 2" x 2" OmniVersa High Conductivity Electrodes

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXY	Electrode, Cutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 Temperature: between 41 and 80.6 Degrees Fahrenheit
Handling Environment Humidity: exactly 35 Percent (%) Relative Humidity
Storage Environment Temperature: between 41 and 80.6 Degrees Fahrenheit
Storage Environment Humidity: exactly 35 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f6ff460-d892-4dba-952c-d1ed9c037d76
Public Version Date: August 29, 2022
Public Version Number: 2
DI Record Publish Date: July 22, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10858703006235	4	00858703006238	In Commercial Distribution	Inner Pack
20858703006232	10	10858703006235	In Commercial Distribution	Case
30858703006239	10	20858703006232	In Commercial Distribution	Display Shipper