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Irrisept Wound Solution Kit

FDA UDI

Class U (US FDA UDI)

by Irrimax Corporation

Identity

Trade Name
Irrisept Wound Solution Kit FDA UDI
Generic Name
Pressure-regulated wound irrigation solution applicator, manual FDA UDI
Device Name
450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP with hanger and spikeable cap. FDA UDI
Model / Reference
ISEPT-WS-USA FDA UDI
Description
450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP with hanger and spikeable cap. FDA UDI

Identifiers

Primary DI / UDI-DI
10842351180010 FDA UDI
510(k) Number
K240552 FDA UDI
FDA Product Code
FRO FDA UDI
FQH FDA UDI
GMDN Term
Pressure-regulated wound irrigation solution applicator, manual FDA UDI

Classification

Device Class
U 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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 Wound Solution Kit by Irrimax Corporation — Class U — 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

K240552 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 8b821054-3f01-429a-9657-2dca013a0bf6 36 fields · synced May 30, 2026