Haier Biomedical

Basic Information

• Brand Name: Haier Biomedical
• Primary DI: 06974440221018
• Version / Model: HCP-160B
• Catalog Number: HCP-160B
• Company Name: Qingdao Haier Biomedical Technology Co.,Ltd.
• Labeler DUNS: 544549733
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-23
• Public Version: 1
• Public Version Date: 2024-05-31
• Public Version Status: New
• Public Device Record Key: 8054cfad-b8af-426d-9a44-a1d9da59e187
• Distribution End Date: 2024-05-23

Device Description

Carbon dioxide laboratory incubator

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
JTQ	Bath, Incubators/Water, All	Microbiology	866.2540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40520	Carbon dioxide laboratory incubator	A mains electricity (AC-powered) incubator in which a fixed temperature and carbon dioxide (CO2) controlled conditions can be achieved and maintained. It is used for the incubation of biological and chemical materials. The percentage mixture of carbon dioxide and other gases, typically oxygen, can be different depending on the use and device type.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974440221018	GS1