Duns Number:961027315
Device Description: Cold Pack, Instant, Non-Sweat
Catalog Number
11440-512
Brand Name
CARDINAL HEALTH
Version/Model Number
11440-512
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2024
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
22bdd956-5ecc-46b3-934b-d0609c5bddeb
Public Version Date
October 20, 2022
Public Version Number
2
DI Record Publish Date
May 21, 2019
Package DI Number
50630140016286
Quantity per Package
4
Contains DI Package
20630140016285
Package Discontinue Date
December 30, 2024
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 |