FDA.reportPublic FDA data

B Medical Systems

Primary DI
05450104540875
Brand
B Medical Systems
Company
B Medical Systems SARL
Model
CSF61S
Catalog number
991.8926.**
Device description
Plasma contact shock freezer
Published
2021-07-01
Public version status
New
Distribution status
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
05450104540875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05450104540875054501045408755450104540875

GMDN Terms#

Term, Definition table
TermDefinition
Rapid-contact laboratory freezerA mains electricity (AC-powered) appliance intended to be used to rapidly freeze bags containing plasma or other biological specimens to a core temperature of -30° Celsius (-22° Fahrenheit). It typically consists of a single or multiple shelves with adjustable contact plates, between which the bags are placed for freezing. It is not intended for storage; frozen bags are subsequently transferred to an appropriate storage freezer. It has sensors, controls, and monitors to display freezing progress (time/temperature graphs). It may include associated software for documentation of data and tracing of the bags.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-30 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
377142935
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
05450104061837B Medical SystemsMT100991.2370.**2022-06-08
05450104548390B Medical SystemsPF260991.8346.**2020-03-04
05450104519161B Medical SystemsMP380CS991.6789.**2020-02-11
05450104537721B Medical SystemsPF260991.8346.032018-09-27
05450104532450B Medical SystemsMP380CS991.6789.522018-09-27
05450104548031B Medical SystemsCSF61S991.8936.**2021-07-09
05450104537929B Medical SystemsCSF61L991.8906.**2021-06-18
05450104551512B Medical SystemsU201991.8643.**2021-05-03
05450104548314B Medical SystemsB291991.8326.**2020-06-17
05450104548338B Medical SystemsP290991.8326.**2020-06-17
05450104548345B Medical SystemsB381991.8336.**2020-05-04
05450104548253B Medical SystemsB51991.8306.**2020-04-17
05450104548284B Medical SystemsB131991.8316.**2020-03-04
05450104493294B Medical SystemsBR250G991.6627.**2020-02-11
05450104494284B Medical SystemsBR410G991.6637.**2020-02-11
05450104495540B Medical SystemsBR490G991.6647.**2020-02-11
05450104496400B Medical SystemsBR750G991.6657.**2020-02-11
05450104513060B Medical SystemsBR110G991.6617.**2020-02-11
05450104532122B Medical SystemsBR110G991.6617.512016-10-17
05450104532139B Medical SystemsBR110G991.6617.522016-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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