Irrisept 9001

GUDID 10842351190019

Irrisept Wound Debridment and Cleansing System

IRRIMAX CORPORATION

Pressure-regulated wound irrigation solution applicator, manual
Primary Device ID10842351190019
NIH Device Record Key134e062c-25ab-4747-9ef8-c90faab1adae
Commercial Distribution Discontinuation2018-11-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIrrisept
Version Model NumberISEPT-450-STU
Catalog Number9001
Company DUNS142661078
Company NameIRRIMAX CORPORATION
Device Count12
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com
Phone+1(844)232-9123
Emailudiconnect@irrisept.com

Device Dimensions

Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter
Total Volume450 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100842351190012 [Unit of Use]
GS110842351190019 [Primary]

FDA Product Code

FQHLAVAGE, JET

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-02-24
Device Publish Date2018-10-01

On-Brand Devices [Irrisept]

10842351190019Irrisept Wound Debridment and Cleansing System
10842351190002Irrisept Wound Debridment and Cleansing System
10842351180003Irrisept Wound Debridment and Cleansing System
10842351110000Irrisept Wound Debridment and Cleansing System
10842351100056Clinical Research Wound Debridment and Cleansing System
10842351100032Irrisept Wound Debridment and Cleansing System

Trademark Results [Irrisept]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IRRISEPT
IRRISEPT
78932784 3732893 Live/Registered
Innovation Technologies, Inc.
2006-07-19

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