FDA.reportPublic FDA data

Follett

Primary DI
00857117006933
Brand
Follett
Company
FOLLETT CORPORATION
Model
REF5BBi-TR-00-00
Device description
Infinity Series Blood Bank Refrigerator, 4.5 cu. Ft.,right side hinge, SS door.
Published
2025-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00857117006933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857117006933008571170069338571170069330857117006933

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002388445
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857117006872FollettREF5BBP-TR-00-002024-12-23
00857117006889FollettREF5BBP-TR-00-GD2024-12-23
00857117006896FollettREF5BBP-TR-KP-GD2024-12-23
00857117006902FollettREF5BBP-TR-KP-002024-12-23
00857117006636FollettREF20i-BB-L0000G015255182023-10-31
00857117006643FollettREF20i-BB-L00KPG015255262023-10-31
00857117006650FollettREF20i-BB-LHT00G015255342023-10-31
00857117006667FollettREF20i-BB-LHTKPG015255422023-10-31
00857117006681FollettREF20i-BB-R00KPG015255672023-10-31
00857117006698FollettREF20i-BB-RHT00G015255752023-10-31
00857117006704FollettREF20i-BB-RHTKPG015255832023-10-31
00857117006711FollettREF25i-BB-L0000G015258492023-10-31
00857117006728FollettREF25i-BB-L00KPG015258562023-10-31
00857117006735FollettREF25i-BB-LHT00G015258642023-10-31
00857117006742FollettREF25i-BB-LHTKPG015258722023-10-31
00857117006766FollettREF25i-BB-R00KPG015258982023-10-31
00857117006773FollettREF25i-BB-RHT00G015259062023-10-31
00857117006780FollettREF25i-BB-RHTKPG015259142023-10-31
00857117006551FollettREF45-BB-0HT00G011581952017-04-20
00857117006568FollettREF45-BB-0HTKPG011582032017-04-20

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