HettCube

Basic Information

• Brand Name: HettCube
• Primary DI: 04050674070898
• Version / Model: HettCube 600R, 220-240V, 50/60 Hz
• Catalog Number: 66005
• Company Name: Andreas Hettich GmbH & Co. KG
• Labeler DUNS: 316403245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-02
• Public Version: 1
• Public Version Date: 2021-09-10
• Public Version Status: New
• Public Device Record Key: 8366a862-93a2-4e94-abc9-dd7297959555

Device Description

A mains electricity (AC-powered) device intended to provide ideal conditions for the growth of microorganisms or mammalian cells in culture by automatically monitoring and controlling temperature, humidity, and gaseous conditions [e.g., carbon dioxide (CO2) and oxygen (O2) concentrations]. It typically consists of multiple shelves which hold cells in culture media (e.g., in microplates, petri dishes, flasks) and may have an integrated robotic transfer arm for loading and unloading the incubator onto other instruments in a clinical or research laboratory environment.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
JTQ	Bath, Incubators/Water, All	Microbiology	866.2540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62304	Automated laboratory incubator	A mains electricity (AC-powered) device intended to provide ideal conditions for the growth of microorganisms or mammalian cells in culture by automatically monitoring and controlling temperature, humidity, and gaseous conditions [e.g., carbon dioxide (CO2) and oxygen (O2) concentrations]. It typically consists of multiple shelves which hold cells in culture media (e.g., in microplates, petri dishes, flasks) and may have an integrated robotic transfer arm for loading and unloading the incubator onto other instruments in a clinical or research laboratory environment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050674070898	GS1