Duns Number:012082397
Device Description: 2 Smart Outlets, 2 Cordless Floor Mats, 1 Economy Cordless Monitor & 2 Remote Reset Button 2 Smart Outlets, 2 Cordless Floor Mats, 1 Economy Cordless Monitor & 2 Remote Reset Buttons
Catalog Number
-
Brand Name
Smart Caregiver
Version/Model Number
433S2FM52EC-SYS
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KMI
Product Code Name
Monitor, Bed Patient
Public Device Record Key
b873ae6a-3da7-462f-9cd5-c9046bf2c0c9
Public Version Date
May 30, 2022
Public Version Number
1
DI Record Publish Date
May 20, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 510 |