Irrisept Rapid Packaging - 150 ml non sterile-Rapid Packaging

GUDID 00842351120026

150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and Splash Accessory

IRRIMAX CORPORATION

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• Primary Device ID: 00842351120026
• NIH Device Record Key: 4afe2ec3-6e36-4ee3-b2bd-d4e471de78a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irrisept Rapid Packaging - 150 ml non sterile-Rapid Packaging
• Version Model Number: ISEPT-150RP-USA
• 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: 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
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com
• Phone: +1(844)232-9123
• Email: udiconnect@irrisept.com

Device Dimensions

• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 Milliliter
• Total Volume: 150 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
• 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	00842351120026 [Unit of Use]
GS1	10842351120023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222804

FDA Product Code

• FQH: LAVAGE, JET

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-28
• Device Publish Date: 2023-04-20

Devices Manufactured by IRRIMAX CORPORATION

• 00842351120026 - Irrisept Rapid Packaging - 150 ml non sterile-Rapid Packaging: 2023-04-28150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and Splash Accessory
• 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.
• 10842351100025 - Irrimax: 2021-02-24 Irrimax Wound Irrigation System
• 10842351100032 - Irrisept: 2021-02-24 Irrisept Wound Debridment and Cleansing System
• 10842351100056 - Irrisept: 2021-02-24 Clinical Research Wound Debridment and Cleansing System