DR181

GUDID M581NEMK1400

DR181 holter recorder w/ 10L patient cable

Northeast Monitoring, Inc.

Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser Electrocardiographic long-term ambulatory recording analyser

Primary Device ID	M581NEMK1400
NIH Device Record Key	86db159f-4a97-4f4c-adda-abcbd2747fe9
Commercial Distribution Status	In Commercial Distribution
Brand Name	DR181
Version Model Number	DR181 12L
Company DUNS	837441815
Company Name	Northeast Monitoring, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram
Length	12.5 Centimeter
Width	7 Centimeter
Width	2.5 Centimeter
Weight	200 Gram

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -40C to 70C

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M581NEMK1400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K001288

FDA Product Code

MWJ	Electrocardiograph, Ambulatory (Without Analysis)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-11-04
Device Publish Date	2021-10-27

On-Brand Devices [DR181]

M581NEMK1400	DR181 holter recorder w/ 10L patient cable
M581NEMK1390	DR181 holter recorder w/ 7L patient cable
M581NEMK1380	DR181 holter recorder w/ 5L patient cable