Unimax

Basic Information

• Brand Name: Unimax
• Primary DI: 04714127862729
• Version / Model: FSE205000
• Company Name: UNIMAX MEDICAL SYSTEMS INC.
• Labeler DUNS: 658122465
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-18
• Public Version: 1
• Public Version Date: 2020-11-26
• Public Version Status: New
• Public Device Record Key: a221c85b-8bea-4694-8888-80271104c29c

Device Description

Smoke Evacuation Tubing

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60836	Laparoscopic plume filter	A sterile device intended to be used during minimally-invasive surgery, in particular laparoscopic surgery, to filter surgical smoke (plume created by, e.g., electrosurgical diathermy, a laser or sonic scalpel) of potentially harmful agents (e.g., noxious chemicals, particulates, viruses, bacteria) without loss of pneumoperitoneum. It is typically a multi-layered filter pouch intended to be connected to a trocar stopcock; it is intended to help protect surgical staff from ambient exposure to potentially harmful agents. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14714127862726	GS1	Paper Box	10	In Commercial Distribution
Primary	04714127862729	GS1
Package	24714127862723	GS1	Shipping Carton	6	In Commercial Distribution