FDA.reportPublic FDA data

Thermo Scientific ™ CryoMed™

Primary DI
00815773020489
Brand
Thermo Scientific ™ CryoMed™
Company
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
Model
TSCM17TA
Catalog number
TSCM17TA
Device description
TSCM17TA; CRF CTS MD 17L w/print 120V, 60 Hz
Published
2021-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00815773020489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815773020489008157730204898157730204890815773020489

GMDN Terms#

Term, Definition table
TermDefinition
Cryogenic laboratory freezer, liquid nitrogenA mains electricity (AC-powered) laboratory appliance designed for extended cell/tissue (e.g., ovum, embryo, bone, cornea) storage, at temperatures below the point when most all biological activity ceases, using liquid nitrogen (LN2) as the cooling and storage agent. LN2 storage provides a temperature of -180? Celsius (-292? Fahrenheit) or colder. The device typically consists of a chamber with two vessels separated by a vacuum space; automatic temperature controls; an external container to replenish the cryogenic fluid; a pressure-relief device, alarm, recorder; and a pressure-control valve. Cells/tissues are immersed in the liquid nitrogen using appropriate sealed containers.

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
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
00815773020380Thermo Scientific ™ CryoMed™TSCM48MLTSCM48ML2021-01-05

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