Total Containment Device (TCD) 480-B40-00-1245

GUDID 00866305000219

The TCD B40 is a bench top, portable device intended for use by appropriately trained and qualified personnel in hospital/laboratory/clinical settings for the purpose of making sterile connections of 3.9 mm to 4.5 mm PVC tubing in blood processing applications.

GENESIS BPS LLC

Laboratory tubing welder

• Primary Device ID: 00866305000219
• NIH Device Record Key: a0436408-9c69-4050-87ba-534d3cc853fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Containment Device (TCD)
• Version Model Number: TCD B40
• Catalog Number: 480-B40-00-1245
• Company DUNS: 141091095
• Company Name: GENESIS BPS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: 1-866-712-5663
• Email: info@genesisbps.com

Device Dimensions

• Height: 5.9 Centimeter
• Height: 5.9 Centimeter
• Height: 5.9 Centimeter
• Height: 5.9 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866305000219 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-29
• Device Publish Date: 2016-08-02

Devices Manufactured by GENESIS BPS LLC

• 00866305000288 - Genesis Tube Stripper: 2025-02-10 The Tube Stripper is a “plier-like” tool used to strip/expel undiluted residual blood, in the PVC tubing segment, back into
• 00866305000264 - Genesis RapidWeld II STW Sterile Tube Welder: 2022-08-03 The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in laboratories, designed for the purpose of making ste
• 10866305000278 - TCD B40 Wafers: 2022-07-27 The TCDB40 Wafer Assembly consists of a copper wafer and plastic holder. The plastic holder is color coded to assist the operato
• 10866305000230 - RapidWeld Blade Module Kit: 2020-01-20 The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built
• 10866305000247 - RapidWeld Blade Module Kit: 2020-01-20 The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built
• 10866305000254 - RapidWeld Blade Module Kit: 2020-01-20 The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built
• 10866305000223 - TCD B40 Wafers: 2019-11-06 The TCD B40 Wafer Assembly consists of a copper wafer and a plastic holder. The plastic holder is color coded to assist the oper
• 00866305000202 - Genesis RapidWeld STW Sterile Tube Welder: 2019-10-29 The Genesis Rapid Weld STW is a medical device used in laboratories, designed for the purpose of making sterile connections in P