FDA.reportPublic FDA data

Irrisept Wound Solution Kit

Primary DI
00842351180013
Brand
Irrisept Wound Solution Kit
Company
IRRIMAX CORPORATION
Model
ISEPT-WS-USA
Device description
450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP with hanger and spikeable cap.
Published
2024-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240552000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240552000Irrisept Antimicrobial Wound LavageIrrimax Corporation2024-06-18FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842351180010PrimaryGS10
00842351180013Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084235118001010842351180010
00842351180013008423511800138423511800130842351180013

GMDN Terms#

Term, Definition table
TermDefinition
Pressure-regulated wound irrigation solution applicator, manualA hand-held manual device in the form of a compressible bottle with a specialized nozzle, intended to be used to apply a pressure-regulated jet stream of non-medicated topical solution (e.g., sterile water, saline) to mechanically irrigate, clean/moisten, and decontaminate a wound. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)232-9123udiconnect@irrisept.com

Regulatory Flags#

DUNS number
142661078
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10842351180027Irrisept Accessory KitISEPT-AK-USA2024-07-22
00842351180020Irrisept Accessory KitISEPT-AK-USA2024-07-22
10842351120047Irrisept Antimicrobial Wound LavageISEPT-150RP-INT2024-07-16
00842351120040Irrisept Antimicrobial Wound LavageISEPT-150RP-INT2024-07-16
10842351180010Irrisept Wound Solution KitISEPT-WS-USA2024-07-01
10842351120023Irrisept Rapid Packaging - 150 ml non sterile-Rapid PackagingISEPT-150RP-USA2023-04-20
10842351120030Irrisept Antimicrobial Wound Lavage - 150 ml sterileISEPT-150-INT2023-04-20
00842351120026Irrisept Rapid Packaging - 150 ml non sterile-Rapid PackagingISEPT-150RP-USA2023-04-20
00842351120033Irrisept Antimicrobial Wound Lavage - 150 ml sterileISEPT-150-INT2023-04-20
10842351120016Irrisept Antimicrobial Wound LavageISEPT-150N-USA2022-12-17
00842351120019Irrisept Antimicrobial Wound LavageISEPT-150N-USA2022-12-17
10842351110093Irrisept Antimicrobial Wound LavageISEPT-500-INT2022-10-21
10842351120009Irrisept Antimicrobial Wound LavageISEPT-150-USA2022-10-21
10842351100032IrriseptIrrisept-40300032016-11-10
10842351100056IrriseptCT-90100052017-02-10
10842351110000IrriseptISEPT-500-CAN10002018-02-12
10842351180003IrriseptAPP-00180002018-08-10
10842351190019IrriseptISEPT-450-STU90012018-10-01
10842351100025IrrimaxMax-10100022017-07-03
10842351190002Irrisept Antimicrobial Wound LavageISEPT-450-USA90002018-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
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00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
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00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08
00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990178Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990260Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990352Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990444Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990536Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06