Gateway NEMK156

GUDID M581NEMK1560

Gateway NEMK156

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	M581NEMK1560
NIH Device Record Key	dc4d23cf-d90a-44dd-b939-5d5d2de09790
Commercial Distribution Status	In Commercial Distribution
Brand Name	Gateway
Version Model Number	Gateway
Catalog Number	NEMK156
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

Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram
Width	3.8 Centimeter
Length	6.7 Centimeter
Depth	1.2 Centimeter
Weight	35 Gram

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term
Special Storage Condition, Specify	Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M581NEMK1560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142424

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

Devices Manufactured by Northeast Monitoring, Inc.

M581NEMK1290 - DR200	2021-11-04 DR200 holter recorder w/ 3L patient cable
M581NEMK1380 - DR181	2021-11-04 DR181 holter recorder w/ 5L patient cable
M581NEMK1390 - DR181	2021-11-04 DR181 holter recorder w/ 7L patient cable
M581NEMK1400 - DR181	2021-11-04 DR181 holter recorder w/ 10L patient cable
M581NEMK1540 - DR300	2021-11-04 DR300 holter recorder w/ 5L patient cable
M581NEMK1550 - DR300	2021-11-04
M581NEMK1560 - Gateway	2021-11-04Gateway NEMK156
M581NEMK1560 - Gateway	2021-11-04 Gateway NEMK156
M581NEMK1570 - DR400	2021-11-04 DR400 holter recorder with NEMEL002/003 patches

Trademark Results [Gateway]

Mark Image Registration \| Serial	Company Trademark Application Date
GATEWAY 98219046 not registered Live/Pending	Portal Biotechnologies, Inc. 2023-10-11
GATEWAY 98146328 not registered Live/Pending	Res-Care, Inc. DBA BrightSpring Health Services 2023-08-23
GATEWAY 97907659 not registered Live/Pending	ZUMEDIA INC. 2023-04-26
GATEWAY 97418384 not registered Live/Pending	Ortho Solutions, LC 2022-05-19
GATEWAY 97085887 not registered Live/Pending	MP Group NV 2021-10-21
GATEWAY 97075964 not registered Live/Pending	Acer Incorporated 2021-10-15
GATEWAY 97075963 not registered Live/Pending	Acer Incorporated 2021-10-15
GATEWAY 90869184 not registered Live/Pending	Mountain View Seeds LLC 2021-08-06
GATEWAY 90692528 not registered Live/Pending	Gateway Business Brokers, LLC 2021-05-05
GATEWAY 90659468 not registered Live/Pending	Mountain View Seeds, Ltd 2021-04-21
GATEWAY 90530773 not registered Live/Pending	DNC Parks & Resorts at KSC, Inc. 2021-02-16
GATEWAY 90528047 not registered Live/Pending	Mountain View Seeds, Ltd 2021-02-12