Duns Number:141091095
Device Description: The Genesis Rapid Weld STW is a medical device used in laboratories, designed for the purp The Genesis Rapid Weld STW is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
Catalog Number
480-RW-2607-00
Brand Name
Genesis RapidWeld STW Sterile Tube Welder
Version/Model Number
GRW-430
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK140187
Product Code
KSB
Product Code Name
Set, Transfer (Blood/Plasma)
Public Device Record Key
83533c16-a519-4c31-930e-26ae04ab520a
Public Version Date
October 29, 2019
Public Version Number
4
DI Record Publish Date
August 02, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |