HALYARD

Basic Information

• Brand Name: HALYARD
• Primary DI: 20885632426855
• Version / Model: 56143
• Company Name: OWENS & MINOR DISTRIBUTION, INC.
• Labeler DUNS: 007941230
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2026-02-11
• Public Version: 1
• Public Version Date: 2026-02-19
• Public Version Status: New
• Public Device Record Key: d6cc8fd7-516a-4a24-94f2-b919d9c3a34d

Device Description

HALYARD SPECTRUM - PROBE COVER KIT, PE W GEL, ELAS BANDS AND TAPE, 4INX24IN

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
44713	Body-surface ultrasound imaging transducer cover	A device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10885632426858	GS1
Primary	20885632426855	GS1

Premarket Submissions

Submission Number	Supplement Number
K222460	000