FDA.report

B Medical Systems

Primary DI
05450104533716
Brand
B Medical Systems
Company
B Medical Systems SARL
Model
MBF21W
Catalog number
991.8065.**
Device description
Plasma contact shock freezer
Published
2017-01-27
Public version status
Update
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
05450104533716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05450104533716054501045337165450104533716

GMDN Terms

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

TypeLowHighCondition
Handling Environment Temperature-30 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
377142935
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

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05450104540875B Medical SystemsCSF61S991.8926.**2021-07-01
05450104537929B Medical SystemsCSF61L991.8906.**2021-06-18
05450104551512B Medical SystemsU201991.8643.**2021-05-03
05450104548291B Medical SystemsL130991.8316.**2020-05-04
05450104548345B Medical SystemsB381991.8336.**2020-05-04
05450104548369B Medical SystemsP380991.8336.**2020-05-04
05450104548383B Medical SystemsLF260991.8346.**2020-05-04
05450104548253B Medical SystemsB51991.8306.**2020-04-17
05450104548260B Medical SystemsL55991.8306.**2020-04-17
05450104548277B Medical SystemsP55991.8306.**2020-04-17
05450104548284B Medical SystemsB131991.8316.**2020-03-04
05450104548307B Medical SystemsP130991.8316.**2020-03-04
05450104548376B Medical SystemsBF261991.8346.**2020-03-04
05450104548390B Medical SystemsPF260991.8346.**2020-03-04
05450104548321B Medical SystemsL290991.8326.**2020-03-02
05450104548352B Medical SystemsL380991.8336.**2020-03-02
05450104493294B Medical SystemsBR250G991.6627.**2020-02-11
05450104493300B Medical SystemsLR250G991.6627.**2020-02-11

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