FDA.reportPublic FDA data

Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature Freezer

Primary DI
10816934023100
Brand
Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature Freezer
Company
KEY SCIENTIFIC INC
Model
TSX60086MA
Catalog number
TSX60086MA
Device description
Ultra Low Temperature (ULT) Freezers TSX Core Series, 600 Box Capacity, 100-230V, 50/60Hz
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
10816934023100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081693402310010816934023100

GMDN Terms#

Term, Definition table
TermDefinition
Ultralow-temperature laboratory freezerA mains electricity (AC-powered) freezer designed for the storage of laboratory products and sample materials, e.g., in vitro diagnostic (IVD) reagents and laboratory tissue/body fluid samples that require extremely low temperatures, usually in the range from -40 to -90? Celsius. It will typically have a corrosion resistant (typically stainless steel) interior minimizing the risk of adulteration, contamination, and/or corrosion of the contents and a shelving configuration appropriate for storage/easy localization of the products. It will typically be programmable, have defrost capabilities, a built-in alarm system to warn against temperature variations, and a recorder to record events.

Contacts#

Phone, Email table
PhoneEmail
828-658-4400marilyn.barry@thermofisher.com

Regulatory Flags#

DUNS number
938286804
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816934023087Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature FreezerTSX40086MATSX40086MA2026-04-10
10816934023094Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature FreezerTSX50086MATSX50086MA2026-04-10
10816934023117Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature FreezerTSX70086MATSX70086MA2026-04-10
10816934020000Thermo Scientific Revco Blood Bank RefrigeratorREB1204AREB1204A2016-09-23
10816934020130Thermo Scientific Revco Blood Bank RefrigeratorREB404DREB404D2016-09-23
10816934020338Thermo Scientific Forma Blood Bank RefrigeratorFRBB404DFRBB404D2016-09-23
10816934020741Thermo Scientific Jewett Blood Bank RefrigeratorCT1-1BCT1-1B2016-09-23
10816934023049Thermo Scientific TSX Universal Series ULT FreezerTSX40086LATSX40086LA2024-04-08
10816934023056Thermo Scientific TSX Universal Series ULT FreezerTSX50086LATSX50086LA2024-04-08
10816934023063Thermo Scientific TSX Universal Series ULT FreezerTSX60086LATSX60086LA2024-04-08
10816934023070Thermo Scientific TSX Universal Series ULT FreezerTSX70086LATSX70086LA2024-04-08
10816934022745 Thermo Scientific TSX Series High-Performance Plasma FreezerTSX1230LYTSX1230LY2022-01-11
10816934022752 Thermo Scientific TSX Series High-Performance Plasma FreezerTSX1230LZTSX1230LZ2022-01-11
10816934022769 Thermo Scientific TSX Series High-Performance Plasma FreezerTSX1230LVTSX1230LV2022-01-11
10816934022790 Thermo Scientific TSX Series High-Performance Plasma FreezerTSX2330LYTSX2330LY2022-01-11
10816934022806 Thermo Scientific TSX Series High-Performance Plasma FreezerTSX2330LZTSX2330LZ2022-01-11
10816934022813 Thermo Scientific TSX Series High-Performance Plasma FreezerTSX2330LVTSX2330LV2022-01-11
10816934022844 Thermo Scientific TSX Series High-Performance Plasma FreezerTSX3030LYTSX3030LY2022-01-11
10816934022851 Thermo Scientific TSX Series High-Performance Plasma FreezerTSX3030LZTSX3030LZ2022-01-11
10816934022868 Thermo Scientific TSX Series High-Performance Plasma FreezerTSX3030LVTSX3030LV2022-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816394021916Helmer ScientificHELMER, INC.KSE2026-05-13
00816394021923Helmer ScientificHELMER, INC.KSE2026-05-13
00816394021961Helmer ScientificHELMER, INC.KSE2026-05-13
00816394021978Helmer ScientificHELMER, INC.KSE2026-05-13
00816394022036Helmer ScientificHELMER, INC.KSE2026-05-13
00816394022043Helmer ScientificHELMER, INC.KSE2026-05-13
00818630019053BRIDGE™ FRIDGE RefrigeratorTACTICAL MEDICAL SOLUTIONS, LLCKSE2026-05-05
00818630019008Expeditionary Refrigerator (xFRIDGE™)TACTICAL MEDICAL SOLUTIONS, LLCKSE2026-04-24
10816934023087Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature FreezerKEY SCIENTIFIC INCKSE2026-04-10
10816934023094Thermo 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
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