Q-Care Rx

Basic Information

• Brand Name: Q-Care Rx
• Primary DI: 00618029831149
• Version / Model: 6982
• Catalog Number: 6982
• Company Name: SAGE PRODUCTS, LLC
• Labeler DUNS: 054326178
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-10
• Public Version: 2
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: ab057354-93fd-4168-a159-de11a562efc7

Device Description

Q-Care Rx, Oral cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse

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
JOL	CATHETER AND TIP, SUCTION	General Hospital	880.6740	2

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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50618029831144	GS1	case	10	In Commercial Distribution
Primary	00618029831149	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Excursion permitted to 15C to 30C See USP Controlled Room Temperature
• Type: Handling Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius