Life Sensing Instruments, Inc.

Basic Information

• Brand Name: Life Sensing Instruments, Inc.
• Primary DI: 00857769008002
• Version / Model: HTS820 Windows 10
• Company Name: LIFE SENSING INSTRUMENTS, INC.
• Labeler DUNS: 080677893
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-11
• Public Version: 2
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: e0e64943-4cbb-44b3-a1d1-0bb34cfd7a96

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37595	Multiple-patient intensive/general healthcare physiologic monitoring system	An assembly of electrically-powered devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of more than one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and bedside patient monitors to provide data from each patient; it often includes programmable alarms, portable radio transmitters (with sensors), receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857769008002	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K896967	000