Duns Number:644544504
Device Description: Basic electric home bed
Catalog Number
-
Brand Name
sentida 03
Version/Model Number
1WIS13233543101
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
cb3e565c-dc0a-46aa-879b-0cd3688fc4eb
Public Version Date
May 18, 2018
Public Version Number
1
DI Record Publish Date
April 17, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 196 |