A1: Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device. Irrisept contains 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP). The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the bottled solution. Irrisept is a Class II Medical Device and an unclassified Combination Product.
A2: The Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
A3: Irrisept’s bottle design allows users to control the delivery pressure of the solution through manual bottle compression. Grasping the bottle firmly, the user can control the direction and pressure desired to effectively loosen and remove wound debris.
A4: Irrisept can be used for all types of wounds.
A7: ISEPT-450-USA and ISEPT-150-USA are manufactured using aseptic processing per ISO13408 Aseptic Processing of Healthcare Products. The bottle, applicator, and packaging are EO-sterilized.
ISEPT-150N-USA and ISEPT-150RP-USA are also manufactured using aseptic processing per ISO13408 Aseptic Processing of Healthcare Products.
A8: Irrisept is a prescription device. FDA regulations require that prescription devices have the following statement “Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.”
A9: Labeling on all Irrisept products state: ‘Wait for approximately one minute, rinse with normal saline for irrigation. Discard any unused solution.’
A10: Labeling on all Irrisept products state ‘Single patient use only’ along with ‘single use only, do not reuse’ symbol.
A11: Labeling on all Irrisept products state Storage Temperature is between 10°- 30° degrees Celsius (50°- 86° Fahrenheit).
A12: Irrisept maintains a 3-year shelf life from the date of manufacture, which is indicated on the pouch label.
A13: The expiration date may be located at the top of the Irrisept product pouch label or on a sticker on the pouch or box
A15: Each LOT of Irrisept is tested to meet a pH range of 5.0 to 7.0.
Customer Service – Please contact the customer service department directly, as needed.
Ordering Information –
REF # ISEPT-450-USA (sold by the case/12 Irrisept units per case)
REF # ISEPT-150-USA (sold by the case/15 Irrisept units per case)
REF # ISEPT-150N-USA (sold by the case/15 Irrisept units per case)
REF # ISEPT-150RP-USA (sold by the case/12 Irrisept units per case)
Requests can be made through this IRRISEPT® website www.irrisept.com.
*PLEASE NOTE: Irrisept is a “Rx Only” product and can only be sampled by a licensed healthcare practitioner.
Irrisept is sold through national and regional medical/surgical distributors in the USA.
There is currently no reimbursement code for Irrisept.
3. Biocompatibility Matrix. Data on file at Irrimax Corp. Lawrenceville, GA.
14. TR 17-017 Irrisept Temperature Excursion Test
15. McDonnell, G. & Russell, A.D. (1999). Antiseptics and Disinfectants; Activity, Action and Resistance. Clin Micro Rev, 12(1), 147-179. https://doi.org/10.1128/cmr.12.1.147