HYGITECH

Basic Information

• Brand Name: HYGITECH
• Primary DI: 03615140001960
• Version / Model: HY-12019
• Catalog Number: HY-12019
• Company Name: HYGITECH
• Labeler DUNS: 279456896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-24
• Public Version: 2
• Public Version Date: 2020-12-15
• Public Version Status: Update
• Public Device Record Key: 6aaab67b-5d69-4ef5-9eb6-cb5e4ffdd52d

Device Description

Specially for implantologists, it can be fixed to any standard PVC tube or to any surgical suction cannula support. Ideal for angulation of the cannula Length: 25cm, 4mm tip

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
10749	Airway suction catheter	A flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03615140001977	GS1	Box	50	In Commercial Distribution
Primary	03615140001960	GS1
Package	03615140001984	GS1	Carton	12	In Commercial Distribution