Klear-Trace

Basic Information

• Brand Name: Klear-Trace
• Primary DI: 00813880022174
• Version / Model: 2000
• Company Name: TRINITY MEDICAL DEVICES INC.
• Labeler DUNS: 078728314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2018-10-15
• Public Version: 2
• Public Version Date: 2023-08-08
• Public Version Status: Update
• Public Device Record Key: f6d1cd31-d9ee-48d9-81f4-909705c851b1

Device Description

Short Term Neonatal/Infant Electrodes

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17460	Neonatal electrocardiographic electrode	A non-sterile electrical conductor applied to a neonatal patient to transmit electrical signals from the body surface to a data measuring/display device (typicaly an electrocardiograph, patient monitor, or patient monitoring system) to produce an electrocardiogram (ECG). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813880022174	GS1
Unit of Use	00813880023218	GS1