FDA.reportPublic FDA data

Irrisept Antimicrobial Wound Lavage

Primary DI
10842351190002
Brand
Irrisept Antimicrobial Wound Lavage
Company
IRRIMAX CORPORATION
Model
ISEPT-450-USA
Catalog number
9000
Device description
450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator.
Published
2018-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842351190002PrimaryGS10
00842351190005Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084235119000210842351190002
00842351190005008423511900058423511900050842351190005

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solution, non-sterileA non-sterile solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridment and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume450Milliliter

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
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
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

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