Genesis RapidWeld II STW Sterile Tube Welder 480-RW-2607-02

GUDID 00866305000264

The Genesis RapidWeld II STW, model GRW-430-02, 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).

GENESIS BPS LLC

Laboratory tubing welder

• Primary Device ID: 00866305000264
• NIH Device Record Key: cf1858e9-2c43-4c09-ab92-8059559806b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesis RapidWeld II STW Sterile Tube Welder
• Version Model Number: GRW-430-02
• Catalog Number: 480-RW-2607-02
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Length: 33 Centimeter
• Height: 9.9 Centimeter
• Width: 14.2 Centimeter
• Weight: 2.5 Kilogram
• Length: 33 Centimeter
• Height: 9.9 Centimeter
• Width: 14.2 Centimeter
• Weight: 2.5 Kilogram
• Length: 33 Centimeter
• Height: 9.9 Centimeter
• Width: 14.2 Centimeter
• Weight: 2.5 Kilogram
• Length: 33 Centimeter
• Height: 9.9 Centimeter
• Width: 14.2 Centimeter
• Weight: 2.5 Kilogram
• Length: 33 Centimeter
• Height: 9.9 Centimeter
• Width: 14.2 Centimeter
• Weight: 2.5 Kilogram
• Length: 33 Centimeter
• Height: 9.9 Centimeter
• Width: 14.2 Centimeter
• Weight: 2.5 Kilogram
• Length: 33 Centimeter
• Height: 9.9 Centimeter
• Width: 14.2 Centimeter
• Weight: 2.5 Kilogram
• Length: 33 Centimeter
• Height: 9.9 Centimeter
• Width: 14.2 Centimeter
• Weight: 2.5 Kilogram
• Length: 33 Centimeter
• Height: 9.9 Centimeter
• Width: 14.2 Centimeter
• Weight: 2.5 Kilogram

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866305000264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK210584

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: 2022-08-03
• Device Publish Date: 2022-07-26

Devices Manufactured by GENESIS BPS LLC

• 00866305000264 - Genesis RapidWeld II STW Sterile Tube Welder: 2022-08-03The Genesis RapidWeld II STW, model GRW-430-02, 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).
• 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
• 00866305000219 - Total Containment Device (TCD): 2019-10-29 The TCD B40 is a bench top, portable device intended for use by appropriately trained and qualified personnel in hospital/labora