Navios EX B91240

GUDID 15099590683276

NAVIOS EX TETRA SOFTWARE V2.0 NEW USER

BECKMAN COULTER IRELAND INC.

Laboratory instrument/analyser application software IVD
Primary Device ID15099590683276
NIH Device Record Key4595d7f2-ca24-40af-be33-5aa79172ab8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavios EX
Version Model NumberTETRA SOFTWARE V2.0 NEW USER
Catalog NumberB91240
Company DUNS985071975
Company NameBECKMAN COULTER IRELAND INC.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590683276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OYEFlow Cytometric Reagents And Accessories.

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 Date2017-07-06

On-Brand Devices [Navios EX]

15099590683276NAVIOS EX TETRA SOFTWARE V2.0 NEW USER
15099590683269NAVIOS EX OFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7
15099590683252NAVIOS EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7
15099590683245NAVIOS EX ACQUISITION NEW USER SOFTWARE V2.0 WIN 7
15099590683009NAVIOS EX FLOW CYTOMETER (6 COLOR/2 LASER)
15099590682996NAVIOS EX FLOW CYTOMETER (8 COLOR/2 LASER)
15099590677466Navios EX Flow Cytometer (10 Color/3 Laser)

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