DR181

Basic Information

• Brand Name: DR181
• Primary DI: M581NEMK1400
• Version / Model: DR181 12L
• 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: 86db159f-4a97-4f4c-adda-abcbd2747fe9

Device Description

DR181 holter recorder w/ 10L patient cable

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: Yes
• 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
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36827	Electrocardiographic long-term ambulatory recording analyser	An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M581NEMK1400	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K001288	000

Device Sizes

Type	Value	Unit	Text
Length	12.5	Centimeter
Width	7.0	Centimeter
Width	2.5	Centimeter
Weight	200	Gram

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Allowed Storage Conditions: -40C to 70C