Duns Number:961027315
Device Description: Cardinal Health Cold Pack Insulated Instant, Medium
Catalog Number
20204
Brand Name
CARDINAL HEALTH
Version/Model Number
20204
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 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
89777746-a0e5-4349-a897-2dec988e2b1d
Public Version Date
July 01, 2019
Public Version Number
2
DI Record Publish Date
April 09, 2019
Package DI Number
50630140039742
Quantity per Package
24
Contains DI Package
00630140039747
Package Discontinue Date
June 30, 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 |