Site-Rite

Basic Information

• Brand Name: Site-Rite
• Primary DI: 00801741037801
• Version / Model: 9001C0197
• Catalog Number: 9001C0197
• Company Name: Bard Access Systems, Inc.
• Labeler DUNS: 044611812
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 3
• Public Version Date: 2024-01-08
• Public Version Status: Update
• Public Device Record Key: ad28a1cb-a147-4ce0-8a29-89578a520f96

Device Description

48" Probe Cover w/Gel, Ultrasound, Sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
Package	20801741037805	GS1	BX	12	In Commercial Distribution
Package	10801741037808	GS1	CA	10	In Commercial Distribution
Primary	00801741037801	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	48	Inch