I-UNICELL Incubator

Basic Information

• Brand Name: I-UNICELL Incubator
• Primary DI: 06925912711049
• Version / Model: I-UNICELL
• Catalog Number: I6101
• Company Name: Shenzhen YHLO Biotech Co., Ltd.
• Labeler DUNS: 420735989
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-26
• Public Version: 1
• Public Version Date: 2022-11-03
• Public Version Status: New
• Public Device Record Key: ae70d583-ab28-461d-bf89-bcf912e75afd

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
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64818	Microplate/tube/assay card incubator IVD	An electrically-powered device intended to be used for the uniform heating of the contents of a microplate, test tube, and/or assay/reagent/test card, as part of an incubation step required during the in vitro diagnostic processing of a clinical specimen. It typically consists of a heat-conducting panel/unit on which the microplate/tube/card is placed, and an electronically-controlled heating element for precise temperature control. It may also be referred to as a heater and may be used as a stand-alone device or a modular component as part of a system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06925912711049	GS1