FDA.reportPublic FDA data

Genesis RapidWeld II STW Sterile Tube Welder

Primary DI
00866305000264
Brand
Genesis RapidWeld II STW Sterile Tube Welder
Company
GENESIS BPS LLC
Model
GRW-430-02
Catalog number
480-RW-2607-02
Device description
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).
Published
2022-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
BK2105840

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2105840

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866305000264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866305000264008663050002648663050002640866305000264

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height9.9Centimeter
Length33Centimeter
Weight2.5Kilogram
Width14.2Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
141091095
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866305000288Genesis Tube StripperHS-0024A-HS-0022025-01-31
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
10866305000254RapidWeld Blade Module KitGRW-430480-RW-2478-032020-01-10
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
10866305000278TCD B40 WafersGENESIS BPS LLCKSB2022-07-19
10866305000230RapidWeld Blade Module KitGENESIS BPS LLCKSB2020-01-10
10866305000247RapidWeld Blade Module KitGENESIS BPS LLCKSB2020-01-10
10866305000254RapidWeld 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