Self Oral Care Kit

Basic Information

• Brand Name: Self Oral Care Kit
• Primary DI: 00618029980021
• Version / Model: 700-083
• Catalog Number: 700-083
• Company Name: SAGE PRODUCTS, LLC
• Labeler DUNS: 054326178
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-10
• Public Version: 3
• Public Version Date: 2022-07-26
• Public Version Status: Update
• Public Device Record Key: d869a7be-d599-4c47-a970-d6ab3d3043c4
• Distribution End Date: 2019-04-30

Device Description

Patient Personal Hygiene Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOL	CATHETER AND TIP, SUCTION	General Hospital	880.6740	2
NSB	Patient personal hygiene kit	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31817	Basic manual toothbrush	An instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.	No	Active
34524	Dental tooth-cleaning solution	A liquid or gel substance intended to be applied by a dental professional to clean tooth surfaces/cavities, often prior to or following a dental procedure (e.g., restoration, implantation). It typically contains appropriate cleaning agents and may be formulated to prevent plaque accumulation and gingivitis. It is often applied with a syringe, which may be included. After application, this device cannot be reused.	No	Active
37434	Dental suction system cannula, single-use	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.	No	Active
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
Package	50618029980026	GS1	case	24	Not in Commercial Distribution	2019-04-30
Primary	00618029980021	GS1

Customer Contacts

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