Duns Number:961027315
Device Description: INSTANT HOT AND COLD PACK, 2
Catalog Number
11443-440R
Brand Name
CARDINAL HEALTH
Version/Model Number
11443-440R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 2018
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
-
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
9426e71d-caad-4a6d-b007-0a872a3ec552
Public Version Date
July 23, 2018
Public Version Number
2
DI Record Publish Date
May 08, 2018
Package DI Number
20888499002897
Quantity per Package
3
Contains DI Package
00888499002893
Package Discontinue Date
June 01, 2018
Package Status
Not in Commercial Distribution
Package Type
PACK
| 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 |