Pure&Clean

Basic Information

• Brand Name: Pure&Clean
• Primary DI: 00852421007393
• Version / Model: None
• Catalog Number: 11WC16-ZRXI
• Company Name: Pure & Clean, LLC
• Labeler DUNS: 045315650
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-08
• Public Version: 1
• Public Version Date: 2023-08-16
• Public Version Status: New
• Public Device Record Key: 5f1f19f0-dd45-4984-bc34-4e8b799886d2

Device Description

Wound Solutions Rx Wound Irrigant Septa Cap 16 oz

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
37207	Surgical/medical procedure irrigation fluid	A solution, typically saline, intended to be used to flush an anatomical site for clearing and cleaning during a surgical/medical procedure (e.g., ocular area during eye surgery, middle ear during an ENT procedure). The solution may be supplied in a prefilled syringe. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852421007393	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	16	Fluid Ounce

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 0 – Degrees Celsius