Genesis RapidWeld STW Sterile Tube Welder

Basic Information

• Brand Name: Genesis RapidWeld STW Sterile Tube Welder
• Primary DI: 00866305000202
• Version / Model: GRW-430
• Catalog Number: 480-RW-2607-00
• Company Name: GENESIS BPS LLC
• Labeler DUNS: 141091095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-02
• Public Version: 4
• Public Version Date: 2019-10-29
• Public Version Status: Update
• Public Device Record Key: 83533c16-a519-4c31-930e-26ae04ab520a

Device Description

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).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSB	Set, Transfer (Blood/Plasma)	Hematology	864.9875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62054	Laboratory tubing welder	A mains electricity (AC-powered) device intended to make a sterile connection (weld) between two segments of plastic tubing (typically blood transfer tubing during blood/blood component processing applications) in a clinical laboratory setting. It is a tabletop device which includes a blade, realignment mechanism, heating element and clamps intended to enable tubing dissection/reconnection while maintaining a closed system (sterile fluid path). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00866305000202	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
BK140187	0

Device Sizes

Type	Value	Unit	Text
Weight	2.5	Kilogram
Width	14.2	Centimeter
Height	9.9	Centimeter
Length	33	Centimeter

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius