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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
Pressure-regulated wound irrigation solution applicator, manual FDA UDI
Device Name
150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and Splash Accessory FDA UDI
Model / Reference
ISEPT-150RP-INT FDA UDI
Description
150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and Splash Accessory FDA UDI

Identifiers

Primary DI / UDI-DI
10842351120047 FDA UDI
510(k) Number
K222804 FDA UDI
FDA Product Code
FQH FDA UDI
FRO FDA UDI
GMDN Term
Pressure-regulated wound irrigation solution applicator, manual 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pressure-regulated wound irrigation solution applicator, manual

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

Similar devices

Also classified as Pressure-regulated wound irrigation solution applicator, manual.

Cleared under the same submission

K222804 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Irrimax Corporation

Sources (1)

  • FDA UDI 2e27ff4e-d203-4711-a779-51896cfdf22e 36 fields · synced May 30, 2026