GoSafe / HomeSafePersonal Help Wriststrap - 7000PHW Personal Help Wriststrap - Lifeline Systems Company

Duns Number:080030042

Device Description: 7000PHW Personal Help Wriststrap

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

7000PHW

Brand Name

GoSafe / HomeSafePersonal Help Wriststrap

Version/Model Number

300000504851

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 22, 2017

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

f51883e5-6615-46c4-9ba3-35ec5254f1e2

Public Version Date

October 19, 2021

Public Version Number

3

DI Record Publish Date

November 22, 2017

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