PureLife Dental

Basic Information

• Brand Name: PureLife Dental
• Primary DI: D79011430011
• Version / Model: 1143001
• Catalog Number: 1143001
• Company Name: PURELIFE, LLC
• Labeler DUNS: 828690904
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-07-01
• Public Version: 2
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: bfdc5a15-93a0-4a92-9341-57b552ec7f95
• Distribution End Date: 2021-07-01

Device Description

White/White Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient comfort, Specially-designed tip ensures optimal suction

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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
DYN	Mouthpiece, Saliva Ejector	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D79011430013	HIBCC	Case	1000	Not in Commercial Distribution	2021-07-01
Primary	D79011430011	HIBCC
Unit of Use	D79011430010	HIBCC

Customer Contacts

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