Duns Number:961027315
Device Description: Hot/Cold Pack
Catalog Number
70304R
Brand Name
CARDINAL HEALTH
Version/Model Number
70304R
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
IME
Product Code Name
Pack, hot or cold, reusable
Public Device Record Key
7fc2ec68-2748-4ef5-948f-b173f8f5597a
Public Version Date
July 23, 2018
Public Version Number
2
DI Record Publish Date
May 07, 2018
Package DI Number
40888499002853
Quantity per Package
12
Contains DI Package
00888499002855
Package Discontinue Date
June 01, 2018
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 |