AccessGUDID - DEVICE: LifeWatch Mobile Cardiac Telemetry 3-Lead (00850725007101)

GUDID

Device Identifier (DI) Information

Brand Name: LifeWatch Mobile Cardiac Telemetry 3-Lead
Version or Model: MCT 3L-International
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lifewatch

Primary DI Number: 00850725007101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 797936734 *Terms of Use

Device Description: 3 Lead Continuous ECG Monitor & Arrhythmia Detector (MCT 3L - International)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DXH	Transmitters And Receivers, Electrocardiograph, Telephone
DSI	Detector And Alarm, Arrhythmia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143359	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 25ee5eba-2e2b-41a8-8678-bf08ddc44aeb
Public Version Date: May 07, 2019
Public Version Number: 4
DI Record Publish Date: September 16, 2016