BIOBASE

Basic Information

• Brand Name: BIOBASE
• Primary DI: 06936895301349
• Version / Model: BK-HW60
• Company Name: Biobase Biodustry(Shandong)Co., Ltd.
• Labeler DUNS: 420046355
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-06
• Public Version: 1
• Public Version Date: 2023-07-14
• Public Version Status: New
• Public Device Record Key: 9fbfc465-171c-401d-a64c-899e869a4919

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JRG	Block, Heating	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36785	General-purpose thermostat	A mains electricity (AC-powered) device designed to maintain a pre-set temperature range, meaning within a defined limited over and under temperature. This device will typically be used to regulate room temperatures, or it may be a device that regulates another medical device to keep it within a predetermined range.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06936895301349	GS1