Irrisept Antimicrobial Wound Lavage

FDA UDI

Class II (US FDA UDI)

by Irrimax Corporation

Identity

Trade Name: Irrisept Antimicrobial Wound Lavage FDA UDI
Generic Name: Antimicrobial wound irrigation solution FDA UDI
Device Name: 450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator. FDA UDI
Model / Reference: ISEPT-450-USA FDA UDI
Description: 450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator. FDA UDI

Identifiers

Catalog Number: 9000 FDA UDI
Primary DI / UDI-DI: 10842351190002 FDA UDI
FDA Product Code: FQH FDA UDI
FRO FDA UDI
GMDN Term: Antimicrobial wound irrigation solution FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5475 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 450 Milliliter FDA UDI

Category: Antimicrobial wound irrigation solution

Irrisept Antimicrobial Wound Lavage by Irrimax Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Irrimax Corporation

Sources (1)

FDA UDI 8c2b72f1-10e4-4771-b0af-e24df0f9d24f 37 fields · synced May 30, 2026