Shur-Clens

Basic Information

• Brand Name: Shur-Clens
• Primary DI: 10860006476035
• Version / Model: 980093
• Company Name: Asept Pak, Inc.
• Labeler DUNS: 005245137
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2025-04-23
• Public Version: 1
• Public Version Date: 2025-05-01
• Public Version Status: New
• Public Device Record Key: af152412-ee63-4920-9b2d-96c080891c05

Device Description

Case of 24 Containers of Sterile Sodium Chloride 0.9%, USP in 120 mL BFS Container.

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQH	Lavage, Jet	General Hospital	880.5475	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62394	Pressure-regulated wound irrigation solution applicator, manual	A hand-held manual device in the form of a compressible bottle with a specialized nozzle, intended to be used to apply a pressure-regulated jet stream of non-medicated topical solution (e.g., sterile water, saline) to mechanically irrigate, clean/moisten, and decontaminate a wound. 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	00860006476038	GS1
Primary	10860006476035	GS1