FDA.report

K2 Scientific, LLC

Primary DI
G136K249SDFSSBB0
Brand
K2 Scientific, LLC
Company
K2 Scientific, LLC
Model
K249SDFSSBB
Catalog number
K249SDF-SS-BB
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.
Published
2022-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KSERefrigerator, Freezer, Blood Storage

Product Code Classifications

CodeDeviceSpecialtyClass
KSERefrigerator, Freezer, Blood StorageHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G136K249SDFSSBB0PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
8002187613dee@k2sci.com

Regulatory Flags

DUNS number
080936069
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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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
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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
G136K249SDRBB0K2 Scientific, LLCK249SDRBBK249SDR-BB2022-01-17
G136K249SDRSSBB0K2 Scientific, LLCK249SDRSSBBK249SDR-SS-BB2022-01-17
G136K212GDRBB0K2 Scientific, LLCK212GDRBBK212GDR-BB2021-10-20
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