FDA.report

B Medical Systems

Primary DI
05450104533983
Brand
B Medical Systems
Company
B Medical Systems SARL
Model
BR750G
Catalog number
991.6657.56
Device description
Blood storage refrigerator
Published
2016-12-22
Public version status
Update
Distribution status
Not 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
05450104533983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05450104533983054501045339835450104533983

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, and alarms which signal unintentional changes in temperature and power failures.

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

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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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