Duns Number:961027315
Device Description: HOT PACK NONTOXIC 1CA/4BX/10EA INSTANT 6IN X 6.5IN DISPOSABLE MEDIUM FOOD GRADE
Catalog Number
11450-040
Brand Name
CARDINAL HEALTH
Version/Model Number
11450-040
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 13, 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"
-
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
93a6fae6-da38-44a8-b5cc-59ef168a4bc6
Public Version Date
June 19, 2019
Public Version Number
1
DI Record Publish Date
June 11, 2019
Package DI Number
50630140013759
Quantity per Package
4
Contains DI Package
20630140013758
Package Discontinue Date
June 12, 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 |