Irrisept Wound Solution Kit

GUDID 00842351180013

Pressure-regulated wound irrigation solution applicator, manual

Primary Device ID	00842351180013
NIH Device Record Key	8b821054-3f01-429a-9657-2dca013a0bf6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Irrisept Wound Solution Kit
Version Model Number	ISEPT-WS-USA
Company DUNS	142661078
Company Name	IRRIMAX CORPORATION
Device Count	10
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	true
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00842351180013 [Unit of Use]
GS1	10842351180010 [Primary]

FRO	Dressing, wound, drug

Steralize Prior To Use	false
Device Is Sterile	true

00842351120040 - Irrisept Antimicrobial Wound Lavage	2024-07-24 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and Splash Accessory
00842351180013 - Irrisept Wound Solution Kit	2024-07-09450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP with hanger and spikeable cap.
00842351180013 - Irrisept Wound Solution Kit	2024-07-09 450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP with hanger and spikeable cap.
00842351120026 - Irrisept Rapid Packaging - 150 ml non sterile-Rapid Packaging	2023-04-28 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and Splash Accessory
00842351120033 - Irrisept Antimicrobial Wound Lavage - 150 ml sterile	2023-04-28 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator.
00842351120019 - Irrisept Antimicrobial Wound Lavage	2023-04-19 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator.
00842351110096 - Irrisept Antimicrobial Wound Lavage	2022-10-31 450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator.
00842351120002 - Irrisept Antimicrobial Wound Lavage	2022-10-31 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator.
10842351100025 - Irrimax	2021-02-24 Irrimax Wound Irrigation System