Irrisept 0005

GUDID 10842351100056

Clinical Research Wound Debridment and Cleansing System

IRRIMAX CORPORATION

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• Primary Device ID: 10842351100056
• NIH Device Record Key: 07ac5c96-1fca-4266-a257-8517b0b0141f
• Commercial Distribution Discontinuation: 2018-07-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Irrisept
• Version Model Number: CT-901
• Catalog Number: 0005
• Company DUNS: 142661078
• Company Name: IRRIMAX CORPORATION
• Device Count: 6
• 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: false
• 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	00842351100059 [Unit of Use]
GS1	10842351100056 [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: 4
• Public Version Date: 2021-02-24
• Device Publish Date: 2017-02-10

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