Duns Number:080030042
Device Description: 7000AHB AutoAlert Button Senior Living
Catalog Number
7000AHB-SL
Brand Name
Senior Living Alert Device AutoAlert with Indicator
Version/Model Number
300000350661
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 12, 2018
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
9ad86ae3-0336-4dd6-aa4c-1242bce27958
Public Version Date
October 19, 2021
Public Version Number
4
DI Record Publish Date
January 01, 2018
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 |