FDA.reportPublic FDA data

Life Sensing Instruments, Inc.

Primary DI
00857769008040
Brand
Life Sensing Instruments, Inc.
Company
LIFE SENSING INSTRUMENTS, INC.
Model
TrensCenter 6.100
Device description
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system
Published
2023-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00857769008040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857769008040008577690080408577690080400857769008040

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
8008461279bthompson@lsi-medical.com

Regulatory Flags#

DUNS number
080677893
Device count
1
Lot or batch
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
00857769008064Life Sensing Instruments, Inc.HTS820 Windows 11 BLE2024-03-19
00857769008071Life Sensing Instruments, Inc.TrensCenter 6.2002024-03-19
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