IRR-080-6F

Basic Information

• Brand Name: IRR-080-6F
• Primary DI: 00607915118259
• Version / Model: IRR-080-6F
• Company Name: APPLIED MEDICAL RESOURCES CORPORATION
• Labeler DUNS: 187129135
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 19ee9e17-f927-466f-ae60-c0d0d482d3da

Device Description

Irrigation Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCA	Catheter, Biliary, Surgical	Gastroenterology, Urology	876.5010	2
DQY	Catheter, Percutaneous	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10730	Irrigation catheter, single-lumen	A flexible tube used to introduce non-drug fluids (e.g., saline solution) into body cavities other than the circulatory system (e.g., ears, wounds, urethra). It consists of a single-lumen tube with end and/or side holes at the distal end; the proximal end is typically connected through a Luer-lock to a syringe or water pumping system. Dedicated devices are used for specific areas of the body (e.g., urinary tract, stomach, colon, uterus). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00607915118259	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	80	Centimeter
Catheter Gauge	6	French