Sage

Basic Information

• Brand Name: Sage
• Primary DI: 00618029830241
• Version / Model: 9001
• Catalog Number: 9001
• Company Name: SAGE PRODUCTS, LLC
• Labeler DUNS: 054326178
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-22
• Public Version: 1
• Public Version Date: 2023-10-30
• Public Version Status: New
• Public Device Record Key: c96975c0-48ec-4104-b35f-02001f80ea70

Device Description

Skin Antisepsis and Oral Cleansing

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: 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
EFW	TOOTHBRUSH, MANUAL	Dental	872.6855	1
NSB	Patient personal hygiene kit	Dental	872.6855	1
KXF	APPLICATOR, ABSORBENT TIPPED, NON-STERILE	General Hospital	880.6025	1
MAC	Decontamination kit	General, Plastic Surgery	878.4014	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
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
48037	Oral care swab	A device designed as a piece of non-treated, absorbent material on a wooden, paper, or plastic stick and intended to moisten and clean a patient's oral cavity to maintain normal mouth patency and hygiene. It is commonly used on intensive care and long-term care patients to administer moisture, mouthwash, or medications to improve the physical condition of the oral cavity and possibly help reduce the incidence of patient infection. It is typically applied to the patient by nursing staff in hospitals and institutions, or attendants in homecare 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	50618029830246	GS1	case	20	In Commercial Distribution
Primary	00618029830241	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store Product Flat. Avoid excessive heat above 40C
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius