Irrisept Antimicrobial Wound Lavage

GUDID 00842351110096

Pressure-regulated wound irrigation solution applicator, manual

Primary Device ID	00842351110096
NIH Device Record Key	889cbb57-7b87-47d2-9106-25bfa6afa809
Commercial Distribution Status	In Commercial Distribution
Brand Name	Irrisept Antimicrobial Wound Lavage
Version Model Number	ISEPT-500-INT
Company DUNS	142661078
Company Name	IRRIMAX CORPORATION
Device Count	12
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
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

Device Issuing Agency	Device ID
GS1	00842351110096 [Unit of Use]
GS1	10842351110093 [Primary]

FQH	LAVAGE, JET

Steralize Prior To Use	false
Device Is Sterile	true

00842351120002	150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and a
00842351110096	450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and a
00842351120019	150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and a
00842351120040	150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and S