Hays Inc

Basic Information

• Brand Name: Hays Inc
• Primary DI: 00860003700853
• Version / Model: HS2100SS
• Catalog Number: HS2100SS
• Company Name: HAYS, INC.
• Labeler DUNS: 079906040
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-04
• Public Version: 2
• Public Version Date: 2021-12-24
• Public Version Status: Update
• Public Device Record Key: 06e21eea-1382-402b-b897-b6f142cc0974

Device Description

Hays Innovations Sterile Short US Probe Cover Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
Primary	00860003700853	GS1
Package	00860003700884	GS1	Inner Case	20	In Commercial Distribution
Package	00860003700891	GS1	Case	6	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K211969	000