FDA.reportPublic FDA data

B Medical Systems

Primary DI
05450104533822
Brand
B Medical Systems
Company
B Medical Systems SARL
Model
FR110G
Catalog number
991.7087.55
Device description
Plasma storage freezer
Published
2016-12-22
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
05450104533822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05450104533822054501045338225450104533822

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).

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
05450104540875B Medical SystemsCSF61S991.8926.**2021-07-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04260688580324KirschPhilipp Kirsch GmbHKSE2026-02-23
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