Irrimax 0002
GUDID 10842351100025
Irrimax Wound Irrigation System
IRRIMAX CORPORATION
Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline, sterile Non-antimicrobial wound irrigation solution, saline Non-antimicrobial wound irrigation solution, saline Non-antimicrobial wound irrigation solution, saline Non-antimicrobial wound irrigation solution, saline Non-antimicrobial wound irrigation solution, saline Non-antimicrobial wound irrigation solution, saline Non-antimicrobial wound irrigation solution, saline Non-antimicrobial wound irrigation solution, saline Non-antimicrobial wound irrigation solution, saline Non-antimicrobial wound irrigation solution, saline Non-antimicrobial wound irrigation solution, saline| Primary Device ID | 10842351100025 |
| NIH Device Record Key | 99cec28b-9dd1-44fa-b312-b045385dabd7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Irrimax |
| Version Model Number | Max-101 |
| Catalog Number | 0002 |
| Company DUNS | 142661078 |
| Company Name | IRRIMAX CORPORATION |
| Device Count | 12 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842351100028 [Unit of Use] |
| GS1 | 10842351100025 [Primary] |
FDA Product Code
| KYZ | SYRINGE, IRRIGATING (NON DENTAL) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-02-24 |
| Device Publish Date | 2017-07-03 |
Devices Manufactured by IRRIMAX CORPORATION
| 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 | 2021-02-24Irrimax Wound Irrigation System |
| 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 |
Trademark Results [Irrimax]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IRRIMAX 78155504 2780824 Live/Registered |
Sentek Pty Ltd 2002-08-19 |
 IRRIMAX 78053970 2890023 Live/Registered |
Innovation Technologies, Inc. 2001-03-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.