FDA.report

B Medical Systems

Primary DI
05450104539077
Brand
B Medical Systems
Company
B Medical Systems SARL
Model
U401
Catalog number
991.8603.01
Device description
Ultra Low Freezer
Published
2019-02-08
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
05450104539077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05450104539077054501045390775450104539077

GMDN Terms

TermDefinition
Ultralow-temperature laboratory freezerA mains electricity (AC-powered) freezer designed for the storage of laboratory products and sample materials, e.g., in vitro diagnostic (IVD) reagents and laboratory tissue/body fluid samples that require extremely low temperatures, usually in the range from -40 to -90? Celsius. It will typically have a corrosion resistant (typically stainless steel) interior minimizing the risk of adulteration, contamination, and/or corrosion of the contents and a shelving configuration appropriate for storage/easy localization of the products. It will typically be programmable, have defrost capabilities, a built-in alarm system to warn against temperature variations, and a recorder to record events.

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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05450104061837B Medical SystemsMT100991.2370.**2022-06-08
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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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