Irrisept 9001

GUDID 10842351190019

Irrisept Wound Debridment and Cleansing System

IRRIMAX CORPORATION

Pressure-regulated wound irrigation solution applicator, manual

• Primary Device ID: 10842351190019
• NIH Device Record Key: 134e062c-25ab-4747-9ef8-c90faab1adae
• Commercial Distribution Discontinuation: 2018-11-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Irrisept
• Version Model Number: ISEPT-450-STU
• Catalog Number: 9001
• Company DUNS: 142661078
• Company Name: IRRIMAX CORPORATION
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com

Device Dimensions

• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter
• Total Volume: 450 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842351190012 [Unit of Use]
GS1	10842351190019 [Primary]

FDA Product Code

• FQH: LAVAGE, JET

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-24
• Device Publish Date: 2018-10-01

On-Brand Devices [Irrisept]

• 10842351190019: Irrisept Wound Debridment and Cleansing System
• 10842351190002: Irrisept Wound Debridment and Cleansing System
• 10842351180003: Irrisept Wound Debridment and Cleansing System
• 10842351110000: Irrisept Wound Debridment and Cleansing System
• 10842351100056: Clinical Research Wound Debridment and Cleansing System
• 10842351100032: Irrisept Wound Debridment and Cleansing System