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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, transfer (blood/plasma)
510(k) Number BK220673
Tradename Sterile Tube Welder (Model: STW6810-RFID)
Device Name Set, Transfer (Blood/Plasma)
Original Applicant
Wuhan BMS Medicaltech Co., Ltd
5th floor,units c/d,building 9,area b,me
Wuhan,  430206, 
Regulation Number864.9875
Classification Product Code
KSB  
Date Received02/14/2022
Decision Date 10/24/2022
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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