Duns Number:961027315
Device Description: HOT/COLD GEL PACK NONTOXIC NONIRRITATING INSULATED 1CA/24EA 4.5IN X 10.5IN REUSABLE LARGE
Catalog Number
80304A
Brand Name
CARDINAL HEALTH
Version/Model Number
80304A
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
-
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
f6dbfede-36f0-43fa-b04d-d1bc9282a616
Public Version Date
June 23, 2022
Public Version Number
1
DI Record Publish Date
June 15, 2022
Package DI Number
50630140039704
Quantity per Package
24
Contains DI Package
00630140039709
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 |