Duns Number:080030042
Device Description: 324PHB Personal Help Buton / Neckcord
Catalog Number
324PHB
Brand Name
HomeSafe Standard Personal Help Pendant
Version/Model Number
300001287651
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)
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
17f09edd-4684-4c92-8b04-e92597c12e53
Public Version Date
October 19, 2021
Public Version Number
2
DI Record Publish Date
May 16, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 92 |