Klear-Trace

GUDID 00813880023119

Long Term Infant/Pediatric Electrodes

TRINITY MEDICAL DEVICES INC.

Neonatal electrocardiographic electrode

• Primary Device ID: 00813880023119
• NIH Device Record Key: 3460499e-bb26-4e00-bda0-080851b4e4a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klear-Trace
• Version Model Number: 4810
• Company DUNS: 078728314
• Company Name: TRINITY MEDICAL DEVICES INC.
• Device Count: 3
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813880023119 [Primary]
GS1	00813880023232 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861364

FDA Product Code

• DRX: Electrode, Electrocardiograph
• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2018-11-15
• Device Publish Date: 2018-10-15

On-Brand Devices [Klear-Trace]

• 00813880023126: Long Term 5 Lead Electrode
• 00813880023119: Long Term Infant/Pediatric Electrodes
• 00813880023102: Long Term Neonatal Electrodes
• 00813880022174: Short Term Neonatal/Infant Electrodes
• 00813880027490: Infant/Pediatric Electrodes