Haier

Basic Information

• Brand Name: Haier
• Primary DI: 06949573559710
• Version / Model: DW-150W209A
• Catalog Number: DW-150W209A
• Company Name: Qingdao Haier Biomedical Co Ltd
• Labeler DUNS: 529121599
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-06
• Public Version: 1
• Public Version Date: 2023-04-14
• Public Version Status: New
• Public Device Record Key: eedccb62-c51c-42d8-bee8-06522eff91d8

Device Description

Cryogenic Freezer

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
KSE	Refrigerator, Freezer, Blood Storage	Hematology	864.9700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16538	Cryogenic temperature control unit	A mains electricity (AC-powered) device designed to keep temperatures in a container between pre-established limits well below the freezing point of water [i.e., cryogenic temperatures, below -130? Celcius (-202? Fahrenheit)]; typically from -150? to -200? Celsius (-238? to -328? Fahrenheit). The device usually includes temperature sensors, thermometers, a display, connecting cables, and sometimes microprocessors and alarms. It is mainly used in healthcare facilities for containers used for preservation of biological tissues (e.g., embryos, bone), in cryosurgical units, and in blood bank cryogenic freezers (e.g., to store red blood cells).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06949573559710	GS1