FDA.reportPublic FDA data

Irrisept Accessory Kit

Primary DI
00842351180020
Brand
Irrisept Accessory Kit
Company
IRRIMAX CORPORATION
Model
ISEPT-AK-USA
Device description
Sterile spikeable cap and hanger with an off-the-shelf vented spike for use with Irrisept Antimicrobial Wound Lavage, 450 mL
Published
2024-07-22
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
10842351180027PrimaryGS10
00842351180020Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084235118002710842351180027
00842351180020008423511800208423511800200842351180020

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
24
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
10842351120047Irrisept Antimicrobial Wound LavageISEPT-150RP-INT2024-07-16
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
00818582013628Puracyn Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.FRO2026-10-16
05059884011164Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011171Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011188Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011195Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011201Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011218Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111385Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072273Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072280Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072457SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072464SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072471SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08