PureLife+ Chair Sleeves

Basic Information

• Brand Name: PureLife+ Chair Sleeves
• Primary DI: D79010841011
• Version / Model: 1084101
• Catalog Number: 1084101
• Company Name: PURELIFE, LLC
• Labeler DUNS: 828690904
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 225
• 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: f32f3471-cf9c-46e1-9cf1-6d4166619c9f

Device Description

PureLife+ Chair Sleeves, Half - 24" x 27 1/2", High-quality, clear plastic chair sleeves

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: No
• 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
NRD	Unit, operative dental, accessories	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. 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	D79010841010	HIBCC
Primary	D79010841011	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K190484	000