Duns Number:867673159
Device Description: Patient RoomRecliners Product Description: 3 Position Recliner,ExtraWide,1/cs
Catalog Number
-
Brand Name
Drive
Version/Model Number
D574EW-R
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
FRJ
Product Code Name
CHAIR, GERIATRIC
Public Device Record Key
3be5adad-6f68-44d6-b40e-19eac6df7238
Public Version Date
July 16, 2019
Public Version Number
3
DI Record Publish Date
July 10, 2017
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 | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |