Duns Number:625272232
Device Description: Two male luers to one spike port and one female luer with 20cm SCD tubing with pinch clamp Two male luers to one spike port and one female luer with 20cm SCD tubing with pinch clamps.
Catalog Number
-
Brand Name
Accessories
Version/Model Number
40-PF-2M
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
KJG
Product Code Name
Tube, Tissue Culture
Public Device Record Key
8fbf45a4-4ab7-407e-9afe-fd76cd0a67d7
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
August 14, 2018
Package DI Number
20816203023432
Quantity per Package
12
Contains DI Package
10816203023435
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| U | Unclassified | 44 |