Duns Number:625272232
Device Description: One female luer to 9 male luers, 45cm PVC tubing, with pinch clamps
Catalog Number
45-F-9M
Brand Name
Accessory Set
Version/Model Number
45-F-9M
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
c040fc66-4a1d-4361-ad48-9c7362582efd
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
March 06, 2017
Package DI Number
20816203023197
Quantity per Package
10
Contains DI Package
10816203023190
Package Discontinue Date
-
Package Status
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| U | Unclassified | 44 |