FDA.reportPublic FDA data

Life Sensing Instruments, Inc.

Primary DI
00857769008064
Brand
Life Sensing Instruments, Inc.
Company
LIFE SENSING INSTRUMENTS, INC.
Model
HTS820 Windows 11 BLE
Device description
Windows 11 Tower which is part of a multi-patient physiologic system.
Published
2024-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSIDetector And Alarm, Arrhythmia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSIDetector And Alarm, ArrhythmiaCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896967000HTS 820 CARDIAC MONITORLife Sensing Instrument Company, Inc.1990-03-19DSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857769008064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857769008064008577690080648577690080640857769008064

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-624-2732bstanley@lsi-medical.com

Regulatory Flags#

DUNS number
080677893
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857769008088Life Sensing Instruments, Inc.TrensCenter 6.3002025-04-01
00857769008057Life Sensing Instruments, Inc.HTS820 Windows 112024-03-19
00857769008071Life Sensing Instruments, Inc.TrensCenter 6.2002024-03-19
00857769008040Life Sensing Instruments, Inc.TrensCenter 6.1002023-11-05
00857769008033Life Sensing Instruments, Inc.TrensCenter VSP 1.1002020-09-11
00857769008026Life Sensing Instruments, Inc.HTS820 Windows 10 BLE2020-07-15
00857769008019Life Sensing Instruments, Inc.TrensCenter 6.0002020-04-28
00857769008002Life Sensing Instruments, Inc.HTS820 Windows 102018-06-11
00864037000309Life Sensing Instruments, Inc.TM8D Transmitter2017-09-12
00864037000316Life Sensing Instruments, Inc.TM8B Transmitter2017-09-12
00864037000323Life Sensing Instruments, Inc.T-Link Receiver2017-09-12
00864037000330Life Sensing Instruments, Inc.HTS820 Windows 72017-09-12
00864037000354Life Sensing Instruments, Inc.TrensCenter 5.3002017-09-12
00864037000378Life Sensing Instruments, Inc.BWI-D2018-04-23
00864037000385Life Sensing Instruments, Inc.TrensCenter VSP 1.0002018-04-23
00864037000392Life Sensing Instruments, Inc.TrensCenter 5.4002018-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20884838119233Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119240Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119769Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
20884838119776Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-04-17
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDSI2026-04-15
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-03-09
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-11-17
00884838128729C6 Monitor A13, VerizonBRAEMAR MANUFACTURING, LLCDSI2025-10-06
00884838128736C6 Monitor A13, T MobileBRAEMAR MANUFACTURING, LLCDSI2025-10-06
06944413838406Patient Monitor Edan Instruments, Inc.DSI2025-09-05
06944413838413Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838420Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838437Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838444Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838451Patient MonitorEdan Instruments, Inc.DSI2025-09-05
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-05-06
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSI2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSI2024-12-19
00884838123717Care AssistPhilips Medical Systems HsgDSI2024-11-27
00884838123724Care AssistPhilips Medical Systems HsgDSI2024-11-27
00850043907046Zio ECG Utilization Software (ZEUS) SystemIRHYTHM TECHNOLOGIES, INC.DSI2024-07-26
06944413815889Patient MonitorEdan Instruments, Inc.DSI2024-06-17
06944413815896Patient MonitorEdan Instruments, Inc.DSI2024-06-17