MALDI Biotyper - smart CA 8604784

GUDID 04251204325734

Biotyper system for clinical use in the USA, with smartbeam laser.

Bruker Daltonik GmbH

Microbial identification mass spectrometry system IVD
Primary Device ID04251204325734
NIH Device Record Keye175690f-36a6-46cc-a953-bf6a249bd240
Commercial Distribution StatusIn Commercial Distribution
Brand NameMALDI Biotyper - smart CA
Version Model Number8604784
Catalog Number8604784
Company DUNS318387958
Company NameBruker Daltonik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)442-2231
Emailms.support.us@bruker.com

Operating and Storage Conditions

Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 and 79500 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *operating altitude
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *non-condensing at 91F
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *non-condensing, for reference only

Device Identifiers

Device Issuing AgencyDevice ID
GS104251204325734 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEXSystem, mass spectrometry, maldi tof, microorganism identification, cultured isolates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-25

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