BMS

Basic Information

• Brand Name: BMS
• Primary DI: 06976052440061
• Version / Model: Metal Wire Cassette
• 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: f301970b-3b3a-42da-9bba-029e10c9ded5

Device Description

Metal Wire Cassette is a disposable part of Sterile Tube Welder

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• 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
Package	16976052440068	GS1		15	In Commercial Distribution
Primary	06976052440061	GS1

Premarket Submissions

Submission Number	Supplement Number
BK220673	0