TCD B40 Wafers 480-B40-00-1274

GUDID 10866305000223

The TCD B40 Wafer Assembly consists of a copper wafer and a plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion.The wafer assembly is placed in the device prior to the weld process. During the welding process the copper wafer is separated from the plastic holder, and after welding is completed, both the holder and wafer are removed from the device and discarded. The wafers are one-time use only and cannot be reused. The TCD B40 device will not operate without a wafer assembly inserted and will not operate with a used wafer. The TCD B40 wafer assemblies are packaged in boxes containing 240 wafer assemblies in each box referred to as a case.

GENESIS BPS LLC

Laboratory tubing welder

• Primary Device ID: 10866305000223
• NIH Device Record Key: 828d8e48-615f-4697-90ab-21a54eaf95ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TCD B40 Wafers
• Version Model Number: TCD B40
• Catalog Number: 480-B40-00-1274
• Company DUNS: 141091095
• Company Name: GENESIS BPS LLC
• Device Count: 240
• 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: true
• 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	00866305000226 [Unit of Use]
GS1	10866305000223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK950018

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: 2019-11-06
• Device Publish Date: 2019-10-29

On-Brand Devices [TCD B40 Wafers]

• 10866305000223: The TCD B40 Wafer Assembly consists of a copper wafer and a plastic holder. The plastic holder i
• 10866305000278: The TCDB40 Wafer Assembly consists of a copper wafer and plastic holder. The plastic holder is c