Make a Way ECG Monitor

Basic Information

• Brand Name: Make a Way ECG Monitor
• Primary DI: 08809475370012
• Version / Model: MAW2017
• Company Name: MAKE A WAY CO.,LTD.
• Labeler DUNS: 694219886
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-05
• Public Version: 4
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: 5cc5074f-5b37-43fe-a926-22365897c18e

Device Characteristics

• Single Use: No
• 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: Yes
• PM Exempt: Yes
• 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
HCC	Device, Biofeedback	Neurology	882.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11413	Electrocardiograph, professional, single-channel	A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809475370012	GS1