Irrisept Antimicrobial Wound Lavage

GUDID 00842351120002

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

IRRIMAX CORPORATION

Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual Pressure-regulated wound irrigation solution applicator, manual

• Primary Device ID: 00842351120002
• NIH Device Record Key: c583942f-1eb7-47cb-a40f-1367483ea0c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irrisept Antimicrobial Wound Lavage
• Version Model Number: ISEPT-150-USA
• Company DUNS: 142661078
• Company Name: IRRIMAX CORPORATION
• Device Count: 15
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842351120002 [Unit of Use]
GS1	10842351120009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210536

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: 2022-10-31
• Device Publish Date: 2022-10-21

On-Brand Devices [Irrisept Antimicrobial Wound Lavage]

• 00842351120002: 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and a
• 00842351110096: 450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and a
• 00842351120019: 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and a