Life Sensing Instruments, Inc.

GUDID 00857769008002

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

LIFE SENSING INSTRUMENTS, INC.

Multiple-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 00857769008002
• NIH Device Record Key: e0e64943-4cbb-44b3-a1d1-0bb34cfd7a96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Life Sensing Instruments, Inc.
• Version Model Number: HTS820 Windows 10
• Company DUNS: 080677893
• Company Name: LIFE SENSING INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-624-2732
• Email: bstanley@lsi-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857769008002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896967

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-06-11

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

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