TVAC

Basic Information

• Brand Name: TVAC
• Primary DI: 00855204008013
• Version / Model: TM-909
• Catalog Number: TM-909
• Company Name: TYTEK MEDICAL INC.
• Labeler DUNS: 078589992
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-03
• Public Version: 1
• Public Version Date: 2019-10-11
• Public Version Status: New
• Public Device Record Key: 25f2425b-a690-48c2-bc71-d497cc79233b

Device Description

Disposable portable suction unit

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47368	Emergency airway clearance suction system, manual	A portable assembly of devices, which includes a non-surgical invasive component, intended to manually aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes a manually-powered (hand or foot-operated) suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855204008013	GS1