Duns Number:800777117
Device Description: Pre-moistened swabs to disinfect needleless access sites prior to use. Strip of 8 swabs.
Catalog Number
B123ST
Brand Name
Prevantics® Device Swab Strip
Version/Model Number
B123ST
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132380,K132380
Product Code
LKB
Product Code Name
Pad, Alcohol, Device Disinfectant
Public Device Record Key
dd417768-f15d-44b1-9acc-a2eda28f394a
Public Version Date
August 11, 2020
Public Version Number
1
DI Record Publish Date
August 03, 2020
Package DI Number
10310819001776
Quantity per Package
160
Contains DI Package
00310819001779
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| U | Unclassified | 1 |