FDA.reportPublic FDA data

Biotecno

Primary DI
07908823600151
Brand
Biotecno
Company
BIOTECNO INDUSTRIA E COMERCIO LTDA
Model
BT-1200/560l
Device description
Biotecno Freezer BT-1200/560l
Published
2024-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
07908823600151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908823600151079088236001517908823600151

GMDN Terms#

Term, Definition table
TermDefinition
Blood plasma freezerAn electrically-powered device intended to be used to store and/or transport blood plasma while keeping it frozen (temperatures of or below -18° Celsius). It typically includes internal shelving for storage and easy location of plasma containers (e.g., bags); a corrosion-resistant (typically stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; forced-air circulation and automatic defrost capability; 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
760374974
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
07908823600007BiotecnoBT 1100/102024-08-07
07908823600014BiotecnoBT-1100/1000l2024-08-07
07908823600021BiotecnoBT-1100/140l2024-08-07
07908823600038BiotecnoBT-1100/1500l2024-08-07
07908823600045BiotecnoBT-1100/202024-08-07
07908823600052BiotecnoBT-1100/280l2024-08-07
07908823600069BiotecnoBT-1100/340l2024-08-07
07908823600076BiotecnoBT-1100/420l2024-08-07
07908823600083BiotecnoBT-1100/502024-08-07
07908823600090BiotecnoBT-1100/560l2024-08-07
07908823600106BiotecnoBT-1100/700l2024-08-07
07908823600113BiotecnoBT-1100/80l2024-08-07
07908823600120BiotecnoBT-1200/140l2024-08-07
07908823600137BiotecnoBT-1200/280l 2024-08-06
07908823600144BiotecnoBT-1200/420l2024-08-06
07908823600168BiotecnoBT-1300/335l2024-08-06
07908823600175BiotecnoBT-1300/520l2024-08-06
07908823600182BiotecnoBT-1500/140l2024-08-06
07908823600199BiotecnoBT-1500/280l2024-08-06
07908823600205BiotecnoBT-1500/420l2024-08-06

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