Duns Number:305656662
Device Description: Showering and changing table 1000, 120V, electrically height adjustable with wired remote Showering and changing table 1000, 120V, electrically height adjustable with wired remote control, 1400 mm, with safety rail, white
Catalog Number
R8402000-93
Brand Name
Showering and changing table 1000
Version/Model Number
R8402
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
INQ
Product Code Name
Table, Powered
Public Device Record Key
8a5cf95a-3053-43fe-bd1d-eb013109809f
Public Version Date
February 09, 2021
Public Version Number
2
DI Record Publish Date
June 08, 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 | 319 |