Duns Number:961027315
Device Description: Instant Cold Pack For Perineal
Catalog Number
11500-010R
Brand Name
CARDINAL HEALTH
Version/Model Number
11500-010R
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
Yes
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
49da9933-5ef1-49a8-bda7-56d9a7e34ddb
Public Version Date
July 23, 2018
Public Version Number
2
DI Record Publish Date
May 08, 2018
Package DI Number
00888499002923
Quantity per Package
24
Contains DI Package
00888499002916
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 |