Irrisept 1000
GUDID 10842351110000
Irrisept Wound Debridment and Cleansing System
IRRIMAX CORPORATION
Pressure-regulated wound irrigation solution applicator, manual| Primary Device ID | 10842351110000 |
| NIH Device Record Key | 918d3108-036c-49ab-b14f-2350df2788dc |
| Commercial Distribution Discontinuation | 2018-07-07 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Irrisept |
| Version Model Number | ISEPT-500-CAN |
| Catalog Number | 1000 |
| 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 |
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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842351110003 [Unit of Use] |
| GS1 | 10842351110000 [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 | 2018-02-12 |
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 |
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