Water Standoff Collar

Basic Information

• Brand Name: Water Standoff Collar
• Primary DI: 05704916001346
• Version / Model: UA0671
• Company Name: BK MEDICAL APS
• Labeler DUNS: 310093901
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-30
• Public Version: 2
• Public Version Date: 2026-01-30
• Public Version Status: Update
• Public Device Record Key: ba2903c2-5abf-48fb-8084-1cff97030f51

Device Description

Water Standoff Collar for 20R3 / 9052 Transducer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66195	Ultrasound imaging transducer cover connector	A ring-shaped, collar-like device intended to be used to connect an ultrasound imaging transducer cover to the handle of the transducer. It is made of polymer and/or metallic materials and has flanges/grooves to connect to the parent devices. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05704916001346	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173569	000
K180737	000
K223830	000