Duns Number:112164780
Device Description: Cardinal Health Perineal Cold Pack Instant
Catalog Number
11500-010
Brand Name
CARDINAL HEALTH
Version/Model Number
11500-010
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"
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
IMD
Product Code Name
PACK, HOT OR COLD, DISPOSABLE
Public Device Record Key
971fdf17-f6f6-4d87-a38e-7a6fe20f41b8
Public Version Date
January 28, 2019
Public Version Number
1
DI Record Publish Date
December 28, 2018
Package DI Number
50888499005882
Quantity per Package
24
Contains DI Package
00888499005887
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 | 81 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 111 |