TruLink

Basic Information

• Brand Name: TruLink
• Primary DI: 10841522129797
• Version / Model: AMC
• Catalog Number: 700-0006-32
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC
• Labeler DUNS: 145581588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2023-05-16
• Public Version: 1
• Public Version Date: 2023-05-24
• Public Version Status: New
• Public Device Record Key: ac3a527f-1ef9-4321-a7de-a0be73bebc84

Device Description

LDWR SET,PINCH,ECG 127CM/50IN,5LW/SET,BX/25

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSI	DETECTOR AND ALARM, ARRHYTHMIA	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35562	Electrocardiographic lead set, reusable	A collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00841522129790	GS1
Primary	10841522129797	GS1

Premarket Submissions

Submission Number	Supplement Number
K103142	000