Catalog Number

-

Brand Name

LifeSignal

Version/Model Number

LP1110

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 18, 2021

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172011,K172011,K172011

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

64c71466-d2b3-4fe2-b781-d13c09a5a819

Public Version Date

April 13, 2022

Public Version Number

3

DI Record Publish Date

October 19, 2018

Package DI Number

B353LP11103

Quantity per Package

8

Contains DI Package

B353LP11102

Package Discontinue Date

May 18, 2021

Package Status

Not in Commercial Distribution

Package Type

Large Box