Duns Number:625272232
Device Description: 12ml syringe on a female luer with 15cm sealed SCD tubing
Catalog Number
-
Brand Name
Accessory Sets
Version/Model Number
15-RF12-T
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
6b6d1f3d-e9eb-4783-a04c-c6bcc8fffc05
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
20816203023043
Quantity per Package
25
Contains DI Package
10816203023046
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 |