Marina Medical

Basic Information

• Brand Name: Marina Medical
• Primary DI: 00840306828430
• Version / Model: 300-356
• Catalog Number: 300-356
• Company Name: MARINA MEDICAL INSTRUMENTS, INC.
• Labeler DUNS: 011442279
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-20
• Public Version: 2
• Public Version Date: 2025-01-17
• Public Version Status: Update
• Public Device Record Key: d48f614e-50ec-436a-8e5b-11d2e72335fc

Device Description

Surgifresh Turbo Smoke Evacuator Complete Package, 110v, Footswitch, Wheel, Handle Kit, ULPA Smoke Filter, 5 Prefilters, 5 tubing

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
46686	Endoscopic overtube, reusable	A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840306828430	GS1

Customer Contacts

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