Duns Number:961027315
Device Description: Foley Insertion Tray w/Prefilled 10cc Syringe
Catalog Number
CIT10CCBZK
Brand Name
CARDINAL HEALTH
Version/Model Number
CIT10CCBZK
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHR
Product Code Name
Catheter care tray
Public Device Record Key
d88e7a88-8f65-41a9-a80c-34fa4c1c0a71
Public Version Date
July 19, 2018
Public Version Number
3
DI Record Publish Date
September 14, 2016
Package DI Number
50885380114494
Quantity per Package
20
Contains DI Package
10885380114496
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 |