HYGITECH

Basic Information

• Brand Name: HYGITECH
• Primary DI: 03615140004336
• Version / Model: HY-12033
• Catalog Number: HY-12033
• Company Name: HYGITECH
• Labeler DUNS: 279456896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-16
• Public Version: 1
• Public Version Date: 2020-12-24
• Public Version Status: New
• Public Device Record Key: 5a224611-5529-4b35-9d85-9665a3e7b695

Device Description

Suction waste collector

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

Sterilization

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBR	Unit, Suction Operatory	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10298	Bowl/basin stand	A device that typically consists of a framework designed to support a bowl or basin in a recess at the top of the device. The stand may be stationary or mobile and is typically used in operating theatres, examination rooms, accident and emergency (A&E) rooms, or bedside.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03615140004336	GS1