Holter Analysis Software Apnea

Basic Information

• Brand Name: Holter Analysis Software Apnea
• Primary DI: M582NEMK1270
• Version / Model: Holter Analysis Software Apnea
• Catalog Number: M582NEMK127
• Company Name: Northeast Monitoring, Inc.
• Labeler DUNS: 837441815
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-27
• Public Version: 1
• Public Version Date: 2021-11-04
• Public Version Status: New
• Public Device Record Key: 943319d6-2966-4bc5-a8c0-b443cc161987

Device Description

Holter Analysis Software Apnea

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: Yes
• Has Lot/Batch Number: No
• 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
MNR	Ventilatory Effort Recorder	Anesthesiology	868.2375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43239	Cardiac arrhythmia monitoring system	An assembly of devices comprised of modules or components (e.g., monitors, recorders, amplifiers) intended to be used to continually detect, measure, and display the electrical activity of the heart and to produce a visible or audible signal/alarm when an atrial or ventricular arrhythmia, such as a premature contraction or ventricular fibrillation, exists.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M582NEMK1270	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K081861	000