FDA.reportPublic FDA data

Thermo Scientific Jewett Blood Bank Refrigerator

Primary DI
10816934020710
Brand
Thermo Scientific Jewett Blood Bank Refrigerator
Company
KEY SCIENTIFIC INC
Model
BBR25D-2A
Catalog number
BBR25D-2A
Device description
Jewett 24.7 Cu. Ft. Pass-Through 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
10816934020710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081693402071010816934020710

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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00816394022036Helmer ScientificHELMER, INC.KSE2026-05-13
00816394022043Helmer ScientificHELMER, INC.KSE2026-05-13
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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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