BALLARD™

Basic Information

• Brand Name: BALLARD™
• Primary DI: 10889483565377
• Version / Model: 97021
• Catalog Number: 97021
• Company Name: SUNMED, LLC
• Labeler DUNS: 069009268
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-01
• Public Version: 1
• Public Version Date: 2025-12-09
• Public Version Status: New
• Public Device Record Key: 52364c1c-10b0-414c-a44d-ca750713fe9b

Device Description

BALLARD™ mini 24-HOUR ORAL CARE KIT | Q4

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
NSB	Patient Personal Hygiene Kit	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45172	Oral care kit, single-use	A collection of various devices and supplies used for a patient's oral hygiene. It typically includes an antiseptic applicator swab, a pre-treated toothbrush, mouth swabs, and a mouthwash/oral moisturizer. Its use will improve the physical condition of the oral cavity and may help reduce the incidence of patient infection. It is typically applied by nursing staff in hospitals and institutions, or attendants in home care settings. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889483565377	GS1
Previous	00609038970219	GS1
Package	30889483565371	GS1	Case	16	In Commercial Distribution

Customer Contacts

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