BMS

Basic Information

• Brand Name: BMS
• Primary DI: 06976052440092
• Version / Model: STW6810-RFID
• Company Name: Wuhan BMS Medicaltech Co., Ltd
• Labeler DUNS: 545240228
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-27
• Public Version: 2
• Public Version Date: 2023-05-08
• Public Version Status: Update
• Public Device Record Key: 88edd72b-ed45-448a-adf1-408ff16c97b2

Device Description

Sterile Tube Welder

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSB	Set, Transfer (Blood/Plasma)	Hematology	864.9875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62054	Laboratory tubing welder	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06976052440092	GS1

Premarket Submissions

Submission Number	Supplement Number
BK220673	0