King of Hearts AF

Primary DI
00850725007071
Brand
King of Hearts AF
Company
Lifewatch
Model
King of Hearts AF
Device description
King of Hearts Express AF Cardiac Event Recorder
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSHRecorder, Magnetic Tape, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111745000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111745000KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDERCard Guard Scientific Survival , Ltd.2011-08-01DSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850725007071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850725007071008507250070718507250070710850725007071

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring system transmitterA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-700-3788DL-CCCSupervisors@lifewatch.com

Regulatory Flags#

DUNS number
797936734
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850725007002LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L- Ozone-Verizon2016-09-16
00850725007019LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-ES400-Verizon2016-09-16
00850725007026LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-Brigadier-Verizon2016-09-16
00850725007033LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-Universal Gateway-Verizon2016-09-16
00850725007040LifeWatch Mobile Cardiac Telemetry 1 Lead PatchMCT 1L Patch-Universal Gateway-Verizon2016-09-16
00850725007057MicroERMicroER2016-09-16
00850725007064ExplorerExplorer2016-09-16
00850725007088Lifestar AF ExpressLifestar AF Express2016-09-16
00850725007095LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-ES400-ATT2016-09-16
00850725007101LifeWatch Mobile Cardiac Telemetry 3-LeadMCT 3L-International2016-09-16

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