Life Sensing Instruments, Inc.

GUDID 00857769008026

Windows 10 Tower which is part of a multi-patient physiologic monitoring system.

LIFE SENSING INSTRUMENTS, INC.

Electrocardiography telemetric monitoring system
Primary Device ID00857769008026
NIH Device Record Keyba2aa947-87c8-4f52-92ba-6335c0197dee
Commercial Distribution StatusIn Commercial Distribution
Brand NameLife Sensing Instruments, Inc.
Version Model NumberHTS820 Windows 10 BLE
Company DUNS080677893
Company NameLIFE SENSING INSTRUMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-624-2732
Emailbstanley@lsi-medical.com
Phone800-624-2732
Emailbstanley@lsi-medical.com
Phone800-624-2732
Emailbstanley@lsi-medical.com
Phone800-624-2732
Emailbstanley@lsi-medical.com
Phone800-624-2732
Emailbstanley@lsi-medical.com
Phone800-624-2732
Emailbstanley@lsi-medical.com
Phone800-624-2732
Emailbstanley@lsi-medical.com
Phone800-624-2732
Emailbstanley@lsi-medical.com
Phone800-624-2732
Emailbstanley@lsi-medical.com
Phone800-624-2732
Emailbstanley@lsi-medical.com
Phone800-624-2732
Emailbstanley@lsi-medical.com
Phone800-624-2732
Emailbstanley@lsi-medical.com
Phone800-624-2732
Emailbstanley@lsi-medical.com
Phone800-624-2732
Emailbstanley@lsi-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857769008026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSIDetector And Alarm, Arrhythmia

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-23
Device Publish Date2020-07-15

On-Brand Devices [Life Sensing Instruments, Inc.]

00864037000392Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
00864037000385Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
00864037000378Transmitter which is part of a multi-patient physiologic monitoring system
00864037000354Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
00864037000330Windows 7 Tower which is part of a multi-patient physiologic monitoring system
00864037000323Receiver which is part of a multi-patient physiologic monitoring system
00864037000316Transmitter which is part of a multi-patient physiologic monitoring system
00864037000309Transmitter which is part of a multi-patient physiologic monitoring system
00857769008002Windows 10 Tower which is part of a multi-patient physiologic monitoring system
00857769008019Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
00857769008026Windows 10 Tower which is part of a multi-patient physiologic monitoring system.
00857769008033Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
00857769008040Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system
00857769008071Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system
00857769008064Windows 11 Tower which is part of a multi-patient physiologic system.
00857769008057Windows 11 Tower which is part of a multi-patient physiologic monitoring system
00857769008088Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system

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