Catalog Number

7000PHB

Brand Name

GoSafe / HomeSafePersonal Help Pendant

Version/Model Number

300000504781

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 22, 2017

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ILQ

Product Code Name

System, communication, powered

Public Device Record Key

38347655-0c96-4674-a359-6d8b3aea0b84

Public Version Date

October 19, 2021

Public Version Number

3

DI Record Publish Date

November 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-