FDA.reportPublic FDA data

BMS

Primary DI
06976052440061
Brand
BMS
Company
Wuhan BMS Medicaltech Co., Ltd
Model
Metal Wire Cassette
Device description
Metal Wire Cassette is a disposable part of Sterile Tube Welder
Published
2023-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
BK2206730

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2206730

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16976052440068PackageGS115In Commercial Distribution
06976052440061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697605244006816976052440068
06976052440061069760524400616976052440061

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.

Regulatory Flags#

DUNS number
545240228
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976052440092BMSSTW6810-RFID2023-01-27
16976052440068BMSMetal Wire Cassette2023-01-27

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
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
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
00817827026188AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026195AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026201AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026218AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026676AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
00817827026683AdvectCHARTER MEDICAL, LTD.KSB2019-02-01
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