Igloo® Wound Irrigation OTC

Basic Information

• Brand Name: Igloo® Wound Irrigation OTC
• Primary DI: 00859911004023
• Version / Model: 601
• Catalog Number: 601
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-14
• Public Version: 5
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: ffa3a353-08fd-4474-9fb6-7bc03365a0da
• Distribution End Date: 2023-07-06

Device Description

Wound Irrigation

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYZ	SYRINGE, IRRIGATING (NON DENTAL)	General Hospital	880.6960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13570	Wound shield	A mechanical shield that is designed to form a protective structure over a wound. It may be cage-like and will allow exposure to air and permit access to the injured area while protecting against accidental damage. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20859911004027	GS1		12	Not in Commercial Distribution	2023-07-06
Primary	00859911004023	GS1

Customer Contacts

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