Catalog Number

-

Brand Name

Life Sensing Instruments, Inc.

Version/Model Number

TM8B Transmitter

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K896967

Product Code

DSI

Product Code Name

Detector And Alarm, Arrhythmia

Public Device Record Key

b867c603-790a-41fc-8027-026719befb98

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-