Irrisept 9000
GUDID 10842351190002
Irrisept Wound Debridment and Cleansing System
IRRIMAX CORPORATION
Antimicrobial wound irrigation solution, non-sterile| Primary Device ID | 10842351190002 |
| NIH Device Record Key | 8c2b72f1-10e4-4771-b0af-e24df0f9d24f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Irrisept |
| Version Model Number | ISEPT-450-USA |
| Catalog Number | 9000 |
| 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 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| udiconnect@irrisept.com | |
| Phone | +1(844)232-9123 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 00842351190005 [Unit of Use] |
| GS1 | 10842351190002 [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 | 3 |
| Public Version Date | 2021-02-24 |
| Device Publish Date | 2018-05-01 |
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 |
Trademark Results [Irrisept]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IRRISEPT 78932784 3732893 Live/Registered |
Innovation Technologies, Inc. 2006-07-19 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.