FDA.reportPublic FDA data

Thermo Scientific Forma Blood Bank Refrigerator

Primary DI
10816934020345
Brand
Thermo Scientific Forma Blood Bank Refrigerator
Company
KEY SCIENTIFIC INC
Model
FRBB404V
Catalog number
FRBB404V
Device description
Forma 4.9 Cu. Ft. Blood Bank Refrigerator, 230V/50Hz
Published
2016-09-23
Public version status
Update
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
10816934020345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081693402034510816934020345

GMDN Terms#

Term, Definition table
TermDefinition
Blood refrigeratorAn electrically-powered device intended to be used to store and/or transport whole blood and blood components (e.g., blood cells, plasma) while keeping them cold (temperatures from 1° to 6° Celsius). It may include handles and/or wheels for transportation, internal shelving for storage and easy location of blood containers (e.g., bags); a corrosion-resistant (typically stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; and sensors, controls, monitors, chart recorders (week-long recordings are typical), and alarms (over temperature, under temperature, and power failure).

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
10816934023100Thermo Scientific™ TSX™ Core Series Ultra-Low Temperature FreezerTSX60086MATSX60086MA2026-04-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816394021961Helmer ScientificHELMER, INC.KSE2026-05-13
00816394021978Helmer ScientificHELMER, INC.KSE2026-05-13
00816394022036Helmer ScientificHELMER, INC.KSE2026-05-13
00816394022043Helmer ScientificHELMER, INC.KSE2026-05-13
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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
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00761101151823HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151830HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
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