OmniVersa High Conductivity Electrodes

GUDID 10858703006303

OmniVersa High Conductivity Electrodes, 2.75 x 5

ACCELERATED CARE PLUS CORP

Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 10858703006303
• NIH Device Record Key: af3d1be5-3083-4e98-9745-1e173b46ad48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniVersa High Conductivity Electrodes
• Version Model Number: 26135
• Company DUNS: 828331616
• Company Name: ACCELERATED CARE PLUS CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858703006306 [Primary]
GS1	10858703006303 [Package]; Contains: 00858703006306; Package: Inner Pack [4 Units]; In Commercial Distribution
GS1	20858703006300 [Package]; Package: Case [10 Units]; In Commercial Distribution
GS1	30858703006307 [Package]; Contains: 20858703006300; Package: Display Shipper [10 Units]; In Commercial Distribution

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-01
• Device Publish Date: 2022-07-22

On-Brand Devices [OmniVersa High Conductivity Electrodes]

• 10858703006303: OmniVersa High Conductivity Electrodes, 2.75 x 5
• 10858703006297: OmniVersa High Conductivity Electrodes, 2 x 4
• 10858703006235: 2" x 2" OmniVersa High Conductivity Electrodes