Ultra Low Temperature Freezer

Basic Information

• Brand Name: Ultra Low Temperature Freezer
• Primary DI: 00195648000007
• Version / Model: NUFC09EGSW(US)
• Company Name: WINIADIMCHAE Co., Ltd.
• Labeler DUNS: 688022730
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-06
• Public Version: 1
• Public Version Date: 2021-07-14
• Public Version Status: New
• Public Device Record Key: 03529656-525f-4aca-bbf7-14f01b471901

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
60607	Blood refrigerator/freezer	An electrically-powered device intended to be used to store and/or transport whole blood and/or blood components (e.g., blood cells, plasma) while keeping them cold (temperatures from 1° to 6° Celsius), or alternatively frozen (-18° to -30° Celsius). It includes refrigeration and freezing compartments with internal shelving, controls, sensors and alarms to signal out-of-range temperatures and power failures; its interior is typically corrosion-resistant (typically stainless steel or synthetic materials) to minimize the risk of adulteration, contamination, and/or corrosion of contents. The refrigeration unit is typically equipped with a safety thermostat to protect the products from freezing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195648000007	GS1