HomeSafe Standard Home Communicator - HomeSafe Standard Home Communicator - Lifeline Systems Company

Duns Number:080030042

Device Description: HomeSafe Standard Home Communicator

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More Product Details

Catalog Number

6900AT

Brand Name

HomeSafe Standard Home Communicator

Version/Model Number

300003336611

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

ILQ

Product Code Name

System, communication, powered

Device Record Status

Public Device Record Key

9d648bd9-5baf-4ae4-8c84-916e61116ad8

Public Version Date

October 19, 2021

Public Version Number

2

DI Record Publish Date

April 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFELINE SYSTEMS COMPANY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 92