FDA.reportPublic FDA data

Isotemp™

Primary DI
00815773020571
Brand
Isotemp™
Company
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
Model
IUEC25286LV
Catalog number
IUEC25286LV
Device description
IUEC25286LV; Chest ULT 12.7 cu. ft., 230V, 50Hz
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

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
00815773020571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815773020571008157730205718157730205710815773020571

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791530061
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
00815773020458Thermo Scientific ™ CryoMed™TSCM17CATSCM17CA2021-10-12
00815773020465Thermo Scientific ™ CryoMed™TSCM34CATSCM34CA2021-10-12
00815773020472Thermo Scientific ™ CryoMed™TSCM48CATSCM48CA2021-10-12
00815773020489Thermo Scientific ™ CryoMed™TSCM17TATSCM17TA2021-10-12
00815773020496Thermo Scientific ™ CryoMed™TSCM34TATSCM34TA2021-10-12
00815773020502Thermo Scientific ™ CryoMed™TSCM48TATSCM48TA2021-10-12
00815773020274Thermo Scientific ™ CryoMed™TSCM17MATSCM17MA2021-01-05
00815773020335Thermo Scientific ™ CryoMed™TSCM17MVTSCM17MV2021-01-05
00815773020359Thermo Scientific ™ CryoMed™TSCM34MVTSCM34MV2021-01-05
00815773020373Thermo Scientific ™ CryoMed™TSCM48MVTSCM48MV2021-01-05
00815773020397Thermo Scientific ™ CryoMed™TSCM17EVTSCM17EV2021-01-05
00815773020410Thermo Scientific ™ CryoMed™TSCM34EVTSCM34EV2021-01-05
00815773020434Thermo Scientific ™ CryoMed™TSCM48EVTSCM48EV2021-01-05
00815773020281Thermo Scientific ™ CryoMed™TSCM34MATSCM34MA2021-01-05
00815773020298Thermo Scientific ™ CryoMed™TSCM48MATSCM48MA2021-01-05
00815773020304Thermo Scientific ™ CryoMed™TSCM17EATSCM17EA2021-01-05
00815773020311Thermo Scientific ™ CryoMed™TSCM34EATSCM34EA2021-01-05
00815773020328Thermo Scientific ™ CryoMed™TSCM48EATSCM48EA2021-01-05
00815773020342Thermo Scientific ™ CryoMed™TSCM17MLTSCM17ML2021-01-05
00815773020366Thermo Scientific ™ CryoMed™TSCM34MLTSCM34ML2021-01-05

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
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
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