HERAfreeze Ultra Low Temperature Freezer

Basic Information

• Brand Name: HERAfreeze Ultra Low Temperature Freezer
• Primary DI: 10816934021380
• Version / Model: HDE50040LA
• Catalog Number: HDE50040LA
• Company Name: KEY SCIENTIFIC INC
• Labeler DUNS: 938286804
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-05
• Public Version: 1
• Public Version Date: 2019-11-13
• Public Version Status: New
• Public Device Record Key: 998ff404-56c2-4225-8d9e-6600a6516312

Device Description

HERAfreeze HDE Series -40C Ultra-Low Temperature Freezers

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
40513	Ultralow-temperature laboratory freezer	A mains electricity (AC-powered) freezer designed for the storage of laboratory products and sample materials, e.g., in vitro diagnostic (IVD) reagents and laboratory tissue/body fluid samples that require extremely low temperatures, usually in the range from -40 to -90? Celsius. It will typically have a corrosion resistant (typically stainless steel) interior minimizing the risk of adulteration, contamination, and/or corrosion of the contents and a shelving configuration appropriate for storage/easy localization of the products. It will typically be programmable, have defrost capabilities, a built-in alarm system to warn against temperature variations, and a recorder to record events.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10816934021380	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]