Duns Number:961027315
Device Description: Premium UnderpadsWINGS31" x 36" (78.7 cm x 91.4 cm)Maximum
Catalog Number
UPPM3136
Brand Name
CARDINAL HEALTH
Version/Model Number
UPPM3136
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
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
KME
Product Code Name
BEDDING, DISPOSABLE, MEDICAL
Public Device Record Key
ab008497-98da-49e4-b206-98fa28d13b1f
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
July 29, 2021
Package DI Number
50192253014523
Quantity per Package
4
Contains DI Package
20192253014522
Package Discontinue Date
-
Package Status
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 |