FDA.reportPublic FDA data

RapidWeld Blade Module Kit

Primary DI
10866305000254
Brand
RapidWeld Blade Module Kit
Company
GENESIS BPS LLC
Model
GRW-430
Catalog number
480-RW-2478-03
Device description
The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
Published
2020-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSBSet, Transfer (Blood/Plasma)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSBSet, Transfer (Blood/Plasma)Hematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1401870

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1401870

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10866305000254PrimaryGS10
00866305000257Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086630500025410866305000254
00866305000257008663050002578663050002570866305000257

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory tubing welderA mains electricity (AC-powered) device intended to make a sterile connection (weld) between two segments of plastic tubing (typically blood transfer tubing during blood/blood component processing applications) in a clinical laboratory setting. It is a tabletop device which includes a blade, realignment mechanism, heating element and clamps intended to enable tubing dissection/reconnection while maintaining a closed system (sterile fluid path). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-708-1400info@genesisbps.com

Regulatory Flags#

DUNS number
141091095
Device count
1000
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866305000288Genesis Tube StripperHS-0024A-HS-0022025-01-31
00866305000264Genesis RapidWeld II STW Sterile Tube WelderGRW-430-02480-RW-2607-022022-07-26
10866305000278TCD B40 WafersTCD B40 480-B40-00-20382022-07-19
10866305000230RapidWeld Blade Module KitGRW-430480-RW-2478-012020-01-10
10866305000247RapidWeld Blade Module KitGRW-430480-RW-2478-022020-01-10
10866305000223TCD B40 WafersTCD B40480-B40-00-12742019-10-29
00866305000202Genesis RapidWeld STW Sterile Tube WelderGRW-430480-RW-2607-002016-08-02
00866305000219Total Containment Device (TCD)TCD B40480-B40-00-12452016-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
35020583260314SCD Welding WaferTERUMO BCT, INC.KSB2025-05-14
55020583260318SCD Welding WaferTERUMO BCT, INC.KSB2025-05-14
04987488104139K-Shield Advantage Blood Drawing KitSB-KAWASUMI LABORATORIES, INC.KSB2024-12-24
06976052440061BMSWuhan BMS Medicaltech Co., LtdKSB2023-01-27
16976052440068BMSWuhan BMS Medicaltech Co., LtdKSB2023-01-27
06976052440092BMSWuhan BMS Medicaltech Co., LtdKSB2023-01-27
00866305000264Genesis RapidWeld II STW Sterile Tube WelderGENESIS BPS LLCKSB2022-07-26
10866305000278TCD B40 WafersGENESIS BPS LLCKSB2022-07-19
10866305000230RapidWeld Blade Module KitGENESIS BPS LLCKSB2020-01-10
10866305000247RapidWeld Blade Module KitGENESIS BPS LLCKSB2020-01-10
10866305000223TCD B40 WafersGENESIS BPS LLCKSB2019-10-29
00646311630033BLOOD DRAWING KIT WITH ANTINEEDLE STICK PROTECTOR AND NEEDLELESS ACCESS CONNECTOSB-KAWASUMI LABORATORIES, INC.KSB2019-02-26
00646311630040K-Shield Advantage Blood Drawing KitSB-KAWASUMI LABORATORIES, INC.KSB2019-02-13
00817827026171AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
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00817827026690AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026706AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026713AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00887868260285Rejuvesol™Citra Labs, LLCKSB2018-07-13
14052682004169Fenwal Plasma Transfer Sets with Two SpikesFresenius Kabi AGKSB2018-05-29
24052682004166Fenwal Plasma Transfer Sets with Two SpikesFresenius Kabi AGKSB2018-05-29
00817827026010Advect™CHARTER MEDICAL, LTD.KSB2018-04-10
00817827026027Advect™CHARTER MEDICAL, LTD.KSB2018-04-10
00817827026034Advect™CHARTER MEDICAL, LTD.KSB2018-04-10
00817827026041Advect™CHARTER MEDICAL, LTD.KSB2018-04-10