Duns Number:076916246
Device Description: Full Electric Value Care Bed
Catalog Number
5410VC
Brand Name
Invacare® Full Electric Value Care Bed
Version/Model Number
5410VC
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
LLI
Product Code Name
Bed, therapeutic, ac-powered, adjustable home-use
Public Device Record Key
fabcd427-0341-486c-9a36-ce306bdf2a0d
Public Version Date
May 25, 2020
Public Version Number
1
DI Record Publish Date
May 15, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 136 |
2 | A medical device with a moderate to high risk that requires special controls. | 273 |