TCD B40 Wafers 480-B40-00-2038

GUDID 10866305000278

The TCDB40 Wafer Assembly consists of a copper wafer and plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion. The wafer assembly is placed in the TCDB40 Sterile Tube Welding device prior to the weld process. The copper wafer is separated from the plastic holder during the welding process and after welding is completed both the plastic holder and the copper wafer are removed from the device and discarded. The wafers are single use only and cannot be reused. The TCDB40 Sterile Tube Welding device will not operate without a wafer assembly inserted and will not operate with a used a wafer. The TCDB40 wafer assemblies are packaged in 8 plastic trays. Each tray has 25 individual wafer assemblies. Each box referred to as a case has a total of 200 individual TCDB40 wafer assemblies.

GENESIS BPS LLC

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Primary Device ID10866305000278
NIH Device Record Key6ee13f26-9421-4b71-a74d-0dce6e49fd02
Commercial Distribution StatusIn Commercial Distribution
Brand NameTCD B40 Wafers
Version Model NumberTCD B40
Catalog Number480-B40-00-2038
Company DUNS141091095
Company NameGENESIS BPS LLC
Device Count200
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone201-708-1400
Emailinfo@genesisbps.com
Phone201-708-1400
Emailinfo@genesisbps.com
Phone201-708-1400
Emailinfo@genesisbps.com
Phone201-708-1400
Emailinfo@genesisbps.com
Phone201-708-1400
Emailinfo@genesisbps.com
Phone201-708-1400
Emailinfo@genesisbps.com
Phone201-708-1400
Emailinfo@genesisbps.com
Phone201-708-1400
Emailinfo@genesisbps.com
Phone201-708-1400
Emailinfo@genesisbps.com
Phone201-708-1400
Emailinfo@genesisbps.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100866305000271 [Unit of Use]
GS110866305000278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSBSet, Transfer (Blood/Plasma)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-27
Device Publish Date2022-07-19

On-Brand Devices [TCD B40 Wafers]

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