FDA.reportPublic FDA data

K2 Scientific, LLC

Primary DI
G136K249SDFBB0
Brand
K2 Scientific, LLC
Company
K2 Scientific, LLC
Model
K249SDFBB
Catalog number
K249SDF-BB
Device description
49 Cu. Ft. High-Performance Laboratory, Solid Door, 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-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
Published
2022-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSERefrigerator, Freezer, Blood Storage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSERefrigerator, Freezer, Blood StorageHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G136K249SDFBB0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood refrigerator/freezerAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002187613dee@k2sci.com

Regulatory Flags#

DUNS number
080936069
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G136K225GDRBB0K2 Scientific, LLCK225GDRBBK225GDR-BB2022-01-17
G136K225GDRSSBB0K2 Scientific, LLCK225GDRSSBBK225GDR-SS-BB2022-01-17
G136K225SDFBB0K2 Scientific, LLCK225SDFBBK225SDF-BB2022-01-17
G136K225SDFSSBB0K2 Scientific, LLCK225SDFSSBBK225SDF-SS-BB2022-01-17
G136K225SDRBB0K2 Scientific, LLCK225SDRBBK225SDR-BB2022-01-17
G136K225SDRSSBB0K2 Scientific, LLCK225SDRSSBBK225SDR-SS-BB2022-01-17
G136K230GDRBB0K2 Scientific, LLCK230GDRBBK230GDR-BB2022-01-17
G136K230GDRSSBB0K2 Scientific, LLCK230GDRSSBBK230GDR-SS-BB2022-01-17
G136K230SDRBB0K2 Scientific, LLCK230SDRBBK230SDR-BB2022-01-17
G136K230SDRSSBB0K2 Scientific, LLCK230SDRSSBBK230SDR-SS-BB2022-01-17
G136K249GDRBB0K2 Scientific, LLCK249GDRBBK249GDR-BB2022-01-17
G136K249GDRSDSSBB0K2 Scientific, LLCK249GDRSDSSBBK249GDR-SD-SS-BB2022-01-17
G136K249GDRSSBB0K2 Scientific, LLCK249GDRSSBBK249GDR-SS-BB2022-01-17
G136K249SDFSSBB0K2 Scientific, LLCK249SDFSSBBK249SDF-SS-BB2022-01-17
G136K249SDRBB0K2 Scientific, LLCK249SDRBBK249SDR-BB2022-01-17
G136K249SDRSSBB0K2 Scientific, LLCK249SDRSSBBK249SDR-SS-BB2022-01-17
G136K212GDRBB0K2 Scientific, LLCK212GDRBBK212GDR-BB2021-10-20
G136K215SDFBBBF0K2 Scientific, LLCK215SDFBBBFK215SDF-BB-BF2021-09-03

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Primary DI, Brand, Company table
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