AlveoFlex™ N

GUDID 03760187912011

MAUNA KEA TECHNOLOGIES

Confocal endomicroscopy system probe Confocal endomicroscopy system probe Confocal endomicroscopy system probe Confocal endomicroscopy system probe Confocal endomicroscopy system probe Confocal endomicroscopy system probe Confocal endomicroscopy system probe Confocal endomicroscopy system probe
Primary Device ID03760187912011
NIH Device Record Key43040f1a-f7c6-4277-96ab-cc8747f6c23f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlveoFlex™ N
Version Model NumberFP-10029
Company DUNS394136118
Company NameMAUNA KEA TECHNOLOGIES
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+33170080967
Emailsupport@maunakeatech.com
Phone+33170080967
Emailsupport@maunakeatech.com
Phone+33170080967
Emailsupport@maunakeatech.com
Phone+33170080967
Emailsupport@maunakeatech.com
Phone+33170080967
Emailsupport@maunakeatech.com
Phone+33170080967
Emailsupport@maunakeatech.com
Phone+33170080967
Emailsupport@maunakeatech.com
Phone+33170080967
Emailsupport@maunakeatech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103760187912011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWNConfocal Optical Imaging

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760187912011]

High-level Disinfectant


[03760187912011]

High-level Disinfectant


[03760187912011]

High-level Disinfectant


[03760187912011]

High-level Disinfectant


[03760187912011]

High-level Disinfectant


[03760187912011]

High-level Disinfectant


[03760187912011]

High-level Disinfectant


[03760187912011]

High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-25
Device Publish Date2020-05-15

Devices Manufactured by MAUNA KEA TECHNOLOGIES

03760187913001 - Cellvizio® I.V.E.2024-03-07
03760187910772 - AQ-Flex™ 19-C2023-02-17
03760187912004 - Cellvizio® I.V.E.2020-05-25
03760187912011 - AlveoFlex™ N2020-05-25
03760187912011 - AlveoFlex™ N2020-05-25
03760187912028 - GastroFlex™ N2020-05-25
03760187912035 - ColoFlex™ N2020-05-25
03760187912042 - CystoFlex™ R N2020-05-25
03760187912059 - AQ-Flex™ 19 N2020-05-25

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