Duns Number:961027315
Device Description: Cardinal Health Cold Pack Instant, Extra Small
Catalog Number
103
Brand Name
CARDINAL HEALTH
Version/Model Number
103
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 10, 2019
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
4e2e4d50-bdf9-44ef-9d5b-39d4b69f680c
Public Version Date
May 13, 2019
Public Version Number
2
DI Record Publish Date
January 24, 2019
Package DI Number
40888499007407
Quantity per Package
50
Contains DI Package
20888499007403
Package Discontinue Date
May 10, 2019
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 |