Teknobios

Basic Information

• Brand Name: Teknobios
• Primary DI: G0602023T0
• Version / Model: 1L-2L-5L (hub)
• Catalog Number: 2023.t
• Company Name: Amil Care Corp.
• Labeler DUNS: 082275360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-04
• Public Version: 1
• Public Version Date: 2023-12-12
• Public Version Status: New
• Public Device Record Key: d252f2a8-8cc7-46a7-90df-a8775486bed1

Device Description

Diffuser of ready-to-use liquid solutions

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRJ	Disinfectant, Medical Devices	General Hospital	880.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58215	Airborne device-disinfectant diffuser	A mains electricity (AC-powered) mobile device designed for the automated dispersion of an appropriate disinfectant [e.g., formaldehyde, hydrogen peroxide (H2O2)] into the atmosphere of an enclosed area [e.g., operating room (OR), examination/treatment room] to destroy harmful microorganisms or inhibit their activity on the surfaces of medical devices and equipment after they have been exposed to microbial contamination (bacteria, fungi, viruses, spores of bacteria). It typically consists of a programmable aerosol electrical generator, user controls, tubing and connectors, and a recess for holding a prefilled canister of the disinfectant.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G0602023T0	HIBCC