MediMax Tech

Basic Information

• Brand Name: MediMax Tech
• Primary DI: 00817325023801
• Version / Model: TS3
• Company Name: MEDIMAX TECH INC.
• Labeler DUNS: 927071162
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-16
• Public Version: 1
• Public Version Date: 2020-11-24
• Public Version Status: New
• Public Device Record Key: 4ff31c3d-1866-43d1-a8b2-82232f9ee633

Device Description

TS3 - Laparoscopic Smoke evacuation tube (1 each/ 12 pcs per Case)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GAZ	Tubing, Noninvasive	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46483	Surgical plume evacuation system tube	A sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10817325023808	GS1	Master Case	12	In Commercial Distribution
Primary	00817325023801	GS1

Customer Contacts

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