Total Containment Device (TCD)

FDA UDI

Class II (US FDA UDI)

by Genesisbps Llc

Identity

Trade Name: Total Containment Device (TCD) FDA UDI
Generic Name: Laboratory tubing welder FDA UDI
Device Name: 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. FDA UDI
Model / Reference: TCD B40 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: 480-B40-00-1245 FDA UDI
Primary DI / UDI-DI: 00866305000219 FDA UDI
FDA Product Code: KSB FDA UDI
GMDN Term: Laboratory tubing welder FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.9875 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 1.6 Kilogram FDA UDI
Width — 9.1 Centimeter FDA UDI
Length — 27.2 Centimeter FDA UDI
Height — 5.9 Centimeter FDA UDI

Category: Laboratory tubing welder

Total Containment Device (TCD) by Genesisbps Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory tubing welder.

BMS — Wuhan BMS Medicaltech Co., Ltd · Class II
CompoDock — Fresenius Kabi · Class II
Fenwal Hand Sealer — Fresenius Kabi · Class I
Genesis RapidWeld II STW Sterile Tube Welder — GENESISBPS LLC · Class II
RapidWeld Blade Module Kit — GENESISBPS LLC · Class II
TCD B40 Wafers — GENESISBPS LLC · Class II
RapidWeld Blade Module Kit — GENESISBPS LLC · Class II
Genesis RapidWeld STW Sterile Tube Welder — GENESISBPS LLC · Class II

Cleared under the same submission

BK950018 also covers:

TCD B40 Wafers — GENESISBPS LLC
TCD B40 Wafers — GENESISBPS LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Genesisbps Llc

Sources (1)

FDA UDI a0436408-9c69-4050-87ba-534d3cc853fb 38 fields · synced May 30, 2026