Duns Number:867673159
Device Description: Transport/WheelchairTransport Chairs Product Description: Transport Chair,Alum.19" Silver, Transport/WheelchairTransport Chairs Product Description: Transport Chair,Alum.19" Silver,1/cs
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
ATC19-SL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 2019
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
INN
Product Code Name
CHAIR, ADJUSTABLE, MECHANICAL
Public Device Record Key
8a9f642f-d59b-42b6-b9d0-032f12afb3b3
Public Version Date
July 16, 2019
Public Version Number
3
DI Record Publish Date
May 19, 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 |