FDA.reportPublic FDA data

Irrisept Antimicrobial Wound Lavage

Primary DI
10842351120047
Brand
Irrisept Antimicrobial Wound Lavage
Company
IRRIMAX CORPORATION
Model
ISEPT-150RP-INT
Device description
150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and Splash Accessory
Published
2024-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQHLAVAGE, JET
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222804000Irrisept Antimicrobial Wound LavageIrrimax Corporation2022-09-22FQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842351120047PrimaryGS10
00842351120040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084235112004710842351120047
00842351120040008423511200408423511200400842351120040

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

Contacts#

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

Regulatory Flags#

DUNS number
142661078
Device count
12
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
00842351120040Irrisept Antimicrobial Wound LavageISEPT-150RP-INT2024-07-16
10842351180010Irrisept Wound Solution KitISEPT-WS-USA2024-07-01
00842351180013Irrisept 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
00850022135316VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
00850022135330VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
00850022135347VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28
10841495149815QUIKCLOTTELEFLEX INCORPORATEDFRO2026-07-27
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
B665AVX030011VIA LinxArch Therapeutics, Inc.FRO2026-07-24
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
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08