B Medical Systems 991.8623.01

GUDID 05450104538988

Ultra Low Freezer

B Medical Systems SARL

Ultralow-temperature laboratory freezer
Primary Device ID05450104538988
NIH Device Record Key1bffe6b7-5eb4-4982-82c2-b8bdb0d2dd8a
Commercial Distribution Discontinuation2020-02-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameB Medical Systems
Version Model NumberU701
Catalog Number991.8623.01
Company DUNS377142935
Company NameB Medical Systems SARL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105450104538988 [Primary]

FDA Product Code

KSERefrigerator, Freezer, Blood Storage

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-11
Device Publish Date2019-02-08

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