Irrisept

Basic Information

• Brand Name: Irrisept
• Primary DI: 10842351110000
• Version / Model: ISEPT-500-CAN
• Catalog Number: 1000
• Company Name: IRRIMAX CORPORATION
• Labeler DUNS: 142661078
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2018-02-12
• Public Version: 7
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: 918d3108-036c-49ab-b14f-2350df2788dc
• Distribution End Date: 2022-10-14

Device Description

Irrisept Wound Debridment and Cleansing System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: 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
Primary	10842351110000	GS1
Unit of Use	00842351110003	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	450	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius