Duns Number:961027315
Device Description: Cardinal Health Standard Hot Pack, Small
Catalog Number
11443-512
Brand Name
CARDINAL HEALTH & Design
Version/Model Number
11443-512
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
456e22fb-fc70-469e-a041-c57933486491
Public Version Date
June 28, 2019
Public Version Number
2
DI Record Publish Date
May 30, 2019
Package DI Number
50630140015654
Quantity per Package
4
Contains DI Package
20630140015653
Package Discontinue Date
June 28, 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 |