Irrisept Wound Solution Kit

GUDID 00842351180013

450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP with hanger and spikeable cap.

IRRIMAX CORPORATION

Pressure-regulated wound irrigation solution applicator, manual

• Primary Device ID: 00842351180013
• NIH Device Record Key: 8b821054-3f01-429a-9657-2dca013a0bf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irrisept Wound Solution Kit
• Version Model Number: ISEPT-WS-USA
• Company DUNS: 142661078
• Company Name: IRRIMAX CORPORATION
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• 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

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	00842351180013 [Unit of Use]
GS1	10842351180010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240552

FDA Product Code

• FRO: Dressing, wound, drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-09
• Device Publish Date: 2024-07-01

Devices Manufactured by IRRIMAX CORPORATION

• 00842351180020 - Irrisept Accessory Kit: 2024-07-30 Sterile spikeable cap and hanger with an off-the-shelf vented spike for use with Irrisept Antimicrobial Wound Lavage, 450 mL
• 00842351120040 - Irrisept Antimicrobial Wound Lavage: 2024-07-24 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and Splash Accessory
• 00842351180013 - Irrisept Wound Solution Kit: 2024-07-09450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP with hanger and spikeable cap.
• 00842351180013 - Irrisept Wound Solution Kit: 2024-07-09 450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP with hanger and spikeable cap.
• 00842351120026 - Irrisept Rapid Packaging - 150 ml non sterile-Rapid Packaging: 2023-04-28 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and Splash Accessory
• 00842351120033 - Irrisept Antimicrobial Wound Lavage - 150 ml sterile: 2023-04-28 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator.
• 00842351120019 - Irrisept Antimicrobial Wound Lavage: 2023-04-19 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator.
• 00842351110096 - Irrisept Antimicrobial Wound Lavage: 2022-10-31 450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator.
• 00842351120002 - Irrisept Antimicrobial Wound Lavage: 2022-10-31 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator.