Duns Number:961027315
Device Description: Anti-Fog Solution W/Foam Pad
Catalog Number
CF-1001
Brand Name
CARDINAL HEALTH
Version/Model Number
CF-1001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 01, 2019
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
K932449,K932449
Product Code
OCT
Product Code Name
Anti fog solution and accessories, endoscopy
Public Device Record Key
e337004d-0c16-4dca-a7ee-81f089b78bbe
Public Version Date
November 01, 2019
Public Version Number
6
DI Record Publish Date
September 08, 2016
Package DI Number
50885380009028
Quantity per Package
20
Contains DI Package
10885380009020
Package Discontinue Date
November 01, 2019
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 |