Duns Number:961027315
Device Description: Cardinal Health Anti-Fog Solution and Pad
Catalog Number
CF-1002
Brand Name
CARDINAL HEALTH
Version/Model Number
CF-1002
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"
-
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
OCT
Product Code Name
Anti fog solution and accessories, endoscopy
Public Device Record Key
fac6a323-2809-4e7f-86f1-e80eea7c75cb
Public Version Date
August 16, 2019
Public Version Number
1
DI Record Publish Date
August 08, 2019
Package DI Number
50885380166202
Quantity per Package
39
Contains DI Package
20885380166201
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 |