Duns Number:597723837
Device Description: SCU is a needleless device used to obtain samples from blood culture bottles and to preven SCU is a needleless device used to obtain samples from blood culture bottles and to prevent the risk of a potential needlestick injury.
Catalog Number
A100720
Brand Name
Safety SubCulture Unit (SCU)
Version/Model Number
A100720
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
LIB
Product Code Name
Device, General Purpose, Microbiology, Diagnostic
Public Device Record Key
0e423a09-752d-4fda-baa8-2487d9a1b4ac
Public Version Date
January 22, 2021
Public Version Number
2
DI Record Publish Date
September 19, 2020
Package DI Number
19555240401127
Quantity per Package
60
Contains DI Package
19555240401110
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |