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IRRIMAX CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30057063593005706359IRRIMAX CORPORATION1N2026-01-011665 Lakes Parkway Suite 102 Lawrenceville GA US 30043

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00842351120040Irrisept Antimicrobial Wound Lavage - 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and Splash Accessory+1(844)232-9123udiconnect@irrisept.com
00842351180013Irrisept Wound Solution Kit - 450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP with hanger and spikeable cap.+1(844)232-9123udiconnect@irrisept.com
00842351180020Irrisept Accessory Kit - Sterile spikeable cap and hanger with an off-the-shelf vented spike for use with Irrisept Antimicrobial Wound Lavage, 450 mL+1(844)232-9123udiconnect@irrisept.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
806071362992761K240552Irrisept Antimicrobial Wound LavageFRO2024-06-18
806071295339544K222804Irrisept Antimicrobial Wound LavageFQH2022-09-22
806071578650119K210536Irrisept Antimicrobial Wound LavageFQH2021-05-28
806071127735119K080779IRRISEPT WOUND CLEANSING SYSTEMFQH2009-02-04
806071841648560

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FQH32022-09-22
FRO12024-06-18

PMN#

GUDID#