FDA.report

Kirsch

Primary DI
04260688580331
Brand
Kirsch
Company
Philipp Kirsch GmbH
Model
BL 520 US PRO-ACTIVE
Device description
Blood Bank Refrigerator BL 520 US PRO-ACTIVE
Published
2026-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KSERefrigerator, Freezer, Blood Storage

Product Code Classifications

CodeDeviceSpecialtyClass
KSERefrigerator, Freezer, Blood StorageHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260688580331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260688580331042606885803314260688580331

GMDN Terms

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

Regulatory Flags

DUNS number
316248418
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04260688580348KirschBL 720 US PRO-ACTIVE2026-03-04
04260688580317KirschBL 520 US ULTIMATE2026-02-23
04260688580324KirschBL 720 US ULTIMATE705002026-02-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
00761101151861HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151878HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
10885380193316CARDINAL HEALTHCardinal Health 200, LLCKSE2025-04-15
00857117006933FollettFOLLETT CORPORATIONKSE2025-02-04
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06949573500644Haier BiomedicalQingdao Haier Biomedical Co LtdKSE2025-01-07
06949573563625Haier BiomedicalQingdao Haier Biomedical Co LtdKSE2025-01-07
00857117006872FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006889FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006896FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006902FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006919FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006926FollettFOLLETT CORPORATIONKSE2024-12-23