Duns Number:961027315
Device Description: WHEELCHAIR 300LB 20Wx16D DESK SWNG
Catalog Number
CW0005CS
Brand Name
CARDINAL HEALTH
Version/Model Number
CW0005CS
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
K051481
Product Code
IOR
Product Code Name
Wheelchair, mechanical
Public Device Record Key
e3f673c3-2817-4c1d-a997-ce51e2c2c6bf
Public Version Date
June 11, 2019
Public Version Number
1
DI Record Publish Date
June 03, 2019
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |