Irrisept 0003

GUDID 10842351100032

Pressure-regulated wound irrigation solution applicator, manual

Primary Device ID	10842351100032
NIH Device Record Key	d4f67409-3329-45f4-9057-08b09ddaa7d5
Commercial Distribution Discontinuation	2018-07-07
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Irrisept
Version Model Number	Irrisept-403
Catalog Number	0003
Company DUNS	142661078
Company Name	IRRIMAX CORPORATION
Device Count	6
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	false
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	00842351100035 [Unit of Use]
GS1	10842351100032 [Primary]

FQH	LAVAGE, JET

Steralize Prior To Use	false
Device Is Sterile	true

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

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