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Life Sensing Instruments, Inc.

FDA UDI

Class II (US FDA UDI)

by Life Sensing Instruments, Inc.

Identity

Trade Name
Life Sensing Instruments, Inc. FDA UDI
Generic Name
Electrocardiograph, professional, multichannel FDA UDI
Device Name
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system FDA UDI
Model / Reference
TrensCenter 6.100 FDA UDI
Description
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system FDA UDI

Identifiers

Primary DI / UDI-DI
00857769008040 FDA UDI
510(k) Number
K896967 FDA UDI
FDA Product Code
DSI FDA UDI
GMDN Term
Electrocardiograph, professional, multichannel FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrocardiograph, professional, multichannel

Life Sensing Instruments, Inc. by Life Sensing Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiograph, professional, multichannel.

Cleared under the same submission

K896967 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Life Sensing Instruments, Inc.

Sources (1)

  • FDA UDI 8c946fd8-5e34-494c-939a-f56bde239c68 35 fields · synced May 30, 2026