Duns Number:112164780
Device Description: Collection and Transport Swab Microorganism Collection and Transport System
Catalog Number
C8552-13S
Brand Name
CARDINAL HEALTH
Version/Model Number
C8552-13S
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LIO
Product Code Name
Device, specimen collection
Public Device Record Key
40ab99ee-9240-4281-9328-2ea7b6a826ef
Public Version Date
April 08, 2022
Public Version Number
6
DI Record Publish Date
December 18, 2018
Package DI Number
20885380163569
Quantity per Package
50
Contains DI Package
10885380163562
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 81 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 111 |