FDA.reportPublic FDA data

K2 Scientific, LLC

Primary DI
G136K225SDRBB0
Brand
K2 Scientific, LLC
Company
K2 Scientific, LLC
Model
K225SDRBB
Catalog number
K225SDR-BB
Device description
25 Cu. Ft. High-Performance Laboratory Solid Door Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225SDR-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
G136K225SDRBB0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood refrigeratorAn electrically-powered device intended to be used to store and/or transport whole blood and blood components (e.g., blood cells, plasma) while keeping them cold (temperatures from 1° to 6° Celsius). It may include handles and/or wheels for transportation, internal shelving for storage and easy location of blood containers (e.g., bags); a corrosion-resistant (typically stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; and sensors, controls, monitors, chart recorders (week-long recordings are typical), and alarms (over temperature, under temperature, and power failure).

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
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
G136K249SDFBB0K2 Scientific, LLCK249SDFBBK249SDF-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816394022036Helmer ScientificHELMER, INC.KSE2026-05-13
00816394022043Helmer ScientificHELMER, INC.KSE2026-05-13
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00818630019008Expeditionary Refrigerator (xFRIDGE™)TACTICAL MEDICAL SOLUTIONS, LLCKSE2026-04-24
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10816934023094Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature FreezerKEY SCIENTIFIC INCKSE2026-04-10
10816934023100Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature FreezerKEY SCIENTIFIC INCKSE2026-04-10
10816934023117Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature FreezerKEY SCIENTIFIC INCKSE2026-04-10
04260688580331KirschPhilipp Kirsch GmbHKSE2026-03-04
04260688580348KirschPhilipp Kirsch GmbHKSE2026-03-04
04260688580317KirschPhilipp Kirsch GmbHKSE2026-02-23
04260688580324KirschPhilipp Kirsch GmbHKSE2026-02-23
00857117006957FollettFOLLETT CORPORATIONKSE2026-01-13
00857117006964FollettFOLLETT CORPORATIONKSE2026-01-13
00860015036803Expeditionary RefrigeratorTACTICAL MEDICAL SOLUTIONS, LLCKSE2026-01-07
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