PureLife+ Non-Woven Sponges

Basic Information

• Brand Name: PureLife+ Non-Woven Sponges
• Primary DI: D79011130011
• Version / Model: 1113001
• Catalog Number: 1113001
• Company Name: PURELIFE, LLC
• Labeler DUNS: 828690904
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4000
• 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: 184a30cc-51c8-4b60-8ff0-416db227404b

Device Description

PureLife+ Non-Woven Sponges, 2" x 2", Non-woven, 4ply sponges, Non-sterile, non-linting

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
NAB	Gauze / sponge,nonresorbable for external use	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48131	Non-woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. 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	D79011130010	HIBCC
Primary	D79011130011	HIBCC

Customer Contacts

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