RapidWeld Blade Module Kit 480-RW-2478-03

GUDID 10866305000254

The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.

GENESIS BPS LLC

Laboratory tubing welder

• Primary Device ID: 10866305000254
• NIH Device Record Key: f28a9eab-5336-45d6-88ad-c82d38988f5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RapidWeld Blade Module Kit
• Version Model Number: GRW-430
• Catalog Number: 480-RW-2478-03
• Company DUNS: 141091095
• Company Name: GENESIS BPS LLC
• Device Count: 1000
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 201-708-1400
• Email: info@genesisbps.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866305000257 [Unit of Use]
GS1	10866305000254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK140187

FDA Product Code

• KSB: Set, Transfer (Blood/Plasma)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-20
• Device Publish Date: 2020-01-10

On-Brand Devices [RapidWeld Blade Module Kit]

• 10866305000254: The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade
• 10866305000247: The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade
• 10866305000230: The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade