Irrisept Antimicrobial Wound Lavage

GUDID 00842351120019

150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator.

IRRIMAX CORPORATION

Pressure-regulated wound irrigation solution applicator, manual
Primary Device ID00842351120019
NIH Device Record Key4bbf0f81-edfc-4281-9721-3707fa01f756
Commercial Distribution StatusIn Commercial Distribution
Brand NameIrrisept Antimicrobial Wound Lavage
Version Model NumberISEPT-150N-USA
Company DUNS142661078
Company NameIRRIMAX CORPORATION
Device Count15
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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
Phone+1(844)232-9123
Emailudiconnect@irrisept.com

Device Dimensions

Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 Milliliter
Total Volume150 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
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100842351120019 [Unit of Use]
GS110842351120016 [Primary]

FDA Product Code

FQHLAVAGE, JET

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-04-19
Device Publish Date2022-12-17

On-Brand Devices [Irrisept Antimicrobial Wound Lavage]

00842351120002150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and a
00842351110096450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and a
00842351120019150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and a
00842351120040150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and S

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