Duns Number:961027315
Device Description: Multi-Ring Donut Foam Positioner
Catalog Number
FP-ECWIO
Brand Name
CARDINAL HEALTH
Version/Model Number
FP-ECWIO
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2022
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"
Yes
For Single-Use
Yes
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
CCX
Product Code Name
SUPPORT, PATIENT POSITION
Public Device Record Key
86c4fd2c-f27a-4a8a-baaf-e70dd2075942
Public Version Date
August 01, 2022
Public Version Number
6
DI Record Publish Date
August 28, 2018
Package DI Number
50885380162099
Quantity per Package
36
Contains DI Package
10885380162091
Package Discontinue Date
July 31, 2022
Package Status
Not in Commercial Distribution
Package Type
CASE
| 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 |