FDA.reportPublic FDA data

K2 Scientific, LLC

Primary DI
G136K215SDFBBBF0
Brand
K2 Scientific, LLC
Company
K2 Scientific, LLC
Model
K215SDFBBBF
Catalog number
K215SDF-BB-BF
Device description
15 Cu. Ft., Solid Door, Blood Bank, High-Performance, Plasma Blast Freezer
Published
2021-09-03
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

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
G136K215SDFBBBF0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood plasma freezerAn electrically-powered device intended to be used to store and/or transport blood plasma while keeping it frozen (temperatures of or below -18° Celsius). It typically includes internal shelving for storage and easy location of plasma containers (e.g., bags); a corrosion-resistant (typically stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; forced-air circulation and automatic defrost capability; 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
800-218-7613dee@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
false
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#

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00761101151694HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151700HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151717HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151786HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151793HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151809HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151816HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151823HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151830HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151847HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151854HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151861HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151878HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
10885380193316CARDINAL HEALTHCardinal Health 200, LLCKSE2025-04-15
00857117006933FollettFOLLETT CORPORATIONKSE2025-02-04
00857117006940FollettFOLLETT CORPORATIONKSE2025-02-04
06949573500644Haier BiomedicalQingdao Haier Biomedical Co LtdKSE2025-01-07
06949573563625Haier BiomedicalQingdao Haier Biomedical Co LtdKSE2025-01-07
00857117006872FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006889FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006896FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006902FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006919FollettFOLLETT CORPORATIONKSE2024-12-23