Klear-Trace

GUDID 00813880022174

Short Term Neonatal/Infant Electrodes

TRINITY MEDICAL DEVICES INC.

Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode

• Primary Device ID: 00813880022174
• NIH Device Record Key: f6d1cd31-d9ee-48d9-81f4-909705c851b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klear-Trace
• Version Model Number: 2000
• 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	00813880022174 [Primary]
GS1	00813880023218 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861364

FDA Product Code

• 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