LifeWatch Mobile Cardiac Telemetry 3-Lead

Basic Information

• Brand Name: LifeWatch Mobile Cardiac Telemetry 3-Lead
• Primary DI: 00850725007033
• Version / Model: MCT 3L-Universal Gateway-Verizon
• Company Name: Lifewatch
• Labeler DUNS: 797936734
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2019-05-07
• Public Version Status: Update
• Public Device Record Key: 65194750-e96a-47f8-be3c-f43edb4901e5

Device Description

3 Lead Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon)

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	870.2920	2
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36367	Electrocardiography telemetric monitoring system transmitter	A body-worn, battery-powered component of an electrocardiography telemetric monitoring system designed to continuously measure and wirelessly transmit real-time electrocardiographic (ECG) signals [and sometimes additional parameters such as heart rate, skin temperature, or haemoglobin oxygen saturation (SpO2)] to a remote receiver (e.g., central station server); it may in addition record/analyse data during a period of time for later retrieval (Holter reporting). The transmitter typically includes an antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, and may be provided with dedicated data management/communication software. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850725007033	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K143359	000