Duns Number:961027315
Device Description: PACK HOT/COLD 4.5IN X 10.5IN SOFT FREEZE PACK HEATED IN MICROWAVE FOR WARM THERAPY MEDIUM PACK HOT/COLD 4.5IN X 10.5IN SOFT FREEZE PACK HEATED IN MICROWAVE FOR WARM THERAPY MEDIUM REUSABLE
Catalog Number
70304A
Brand Name
CARDINAL HEALTH
Version/Model Number
70304A
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"
-
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
IME
Product Code Name
Pack, hot or cold, reusable
Public Device Record Key
f713337d-8491-42cc-ae44-182affd39460
Public Version Date
April 16, 2019
Public Version Number
1
DI Record Publish Date
April 08, 2019
Package DI Number
40888499004895
Quantity per Package
6
Contains DI Package
30888499004898
Package Discontinue Date
-
Package Status
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 |