FDA.reportPublic FDA data

PHCbi

Primary DI
04987905300199
Brand
PHCbi
Company
PHC CORPORATION
Model
MDF-U334-PA
Device description
This equipment is designed for low temperature storage of blood and blood products.
Published
2018-04-25
Public version status
Update
Distribution status
Not 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
04987905300199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987905300199049879053001994987905300199

GMDN Terms#

Term, Definition table
TermDefinition
Basic laboratory freezerA mains electricity (AC-powered) freezer designed for the storage of laboratory products, samples, test materials, chemicals or reagents that require low temperatures, usually in the range from -10? to -55? 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, built-in alarm system to warn against temperature variations and a recorder to record events.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
691795268
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987595300011PATHFAST Sample Diluent 1N/A2025-04-18
04987595300028PATHFAST Sample Diluent 2N/A2025-04-18
04987595300646PATHFASTN/A3006462023-06-12
04987595301131PATHFAST cTnI-IIN/A2016-09-22
04987595301230PATHFAST Myo-IIN/A2016-09-22
04987595301339PATHFAST CK-MB-IIN/A2016-09-22
04987595301537PATHFAST D-DimerN/A2016-09-22
04987595301636PATHFAST NTproBNPN/A2016-09-22
04987595301742PATHFAST hsCRPN/A2016-09-22
04987595301803PATHFAST hs-cTnI-IIN/A3018032024-05-01
04987905300236PHCbiMCO-170MG-PA2018-04-25
04987905300205PHCbiMDF-U5312-PA2018-04-25
04987905300212PHCbiMCO-5M-PA2018-04-25
04987905300045PanasonicMCO-170AICUV-PA2016-09-24
04987905300069PanasonicMCO-19M-PA2016-09-24
04987905300076PanasonicMCO-19MUV-PA2016-09-24
04987905300090PanasonicMCO-230AICUV-PA2016-09-24
04987905300113PanasonicMCO-5M-PA2016-09-24
04987905300120PanasonicMCO-170M-PA2016-09-24
04987905300229PHCbiMCO-170M-PA2018-04-25

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