Duns Number:961027315
Device Description: HOT/COLD GEL PACK NONTOXIC NONIRRITATING 1CA/6EA 7.5IN X 15IN REUSABLE JUMBO SIZE
Catalog Number
80600
Brand Name
CARDINAL HEALTH
Version/Model Number
80600
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
IME
Product Code Name
Pack, hot or cold, reusable
Public Device Record Key
7e604f7a-139a-4875-b019-4b1c85b50f2a
Public Version Date
June 14, 2019
Public Version Number
1
DI Record Publish Date
June 06, 2019
Package DI Number
50630140039698
Quantity per Package
6
Contains DI Package
00630140039693
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 |