Duns Number:340866990
Device Description: Basic electric home bed
Catalog Number
-
Brand Name
sentida 7-isentida 7-i wohnlich USA
Version/Model Number
19-1084
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
LLI
Product Code Name
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Public Device Record Key
751b8761-70cf-4d5e-9358-8baf8365f8bf
Public Version Date
October 07, 2020
Public Version Number
1
DI Record Publish Date
September 29, 2020
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. | 7 |