K2 Scientific, LLC

Basic Information

• Brand Name: K2 Scientific, LLC
• Primary DI: G136K249SDFSSBB0
• Version / Model: K249SDFSSBB
• Catalog Number: K249SDF-SS-BB
• Company Name: K2 Scientific, LLC
• Labeler DUNS: 080936069
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-17
• Public Version: 1
• Public Version Date: 2022-01-25
• Public Version Status: New
• Public Device Record Key: f2bb85a2-11cc-4146-8463-f94c6baf217e

Device Description

49 Cu. Ft. High-Performance Laboratory, Solid Door, Stainless Steel, Blood Bank Freezer. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of -25°C with a standard temperature range of -10°C to -30°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K249SDF-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.

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: 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	G136K249SDFSSBB0	HIBCC

Customer Contacts

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