PureLife+ Saliva Ejectors

Basic Information

• Brand Name: PureLife+ Saliva Ejectors
• Primary DI: D79011471021
• Version / Model: 1147102
• Catalog Number: 1147102
• Company Name: PURELIFE, LLC
• Labeler DUNS: 828690904
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2023-06-08
• Public Version: 1
• Public Version Date: 2023-06-16
• Public Version Status: New
• Public Device Record Key: 5e1f0cc8-8c84-4f86-a98f-0145e0f4e75b

Device Description

PureLife+ Saliva Ejectors, Clear/Blue, Low-speed, saliva ejectors, Available in 3 color options

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: 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: Yes
• 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
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
Unit of Use	D79011471020	HIBCC
Primary	D79011471021	HIBCC

Customer Contacts

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